Loestrin Fe 1/20

Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)

Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Loestrin Fe 1/20 (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Loestrin Fe 1/20 (ethinyl estradiol and norethindrone)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Loestrin Fe 1/20 (ethinyl estradiol and norethindrone)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

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  coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

  
  


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  a history of a stroke, blood clot, or circulation problems;

  
  


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  a hormone-related cancer such as breast or uterine cancer;

  
  


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  unusual vaginal bleeding that has not been checked by a doctor;

  
  


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  liver disease or liver cancer;

  
  


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  severe migraine headaches; or

  
  


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  a history of jaundice caused by pregnancy or birth control pills.

  
  

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

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  high blood pressure or a history of heart disease;

  
  


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  high cholesterol, gallbladder disease, or diabetes;

  
  


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  migraine headaches or a history of depression; or

  
  


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  a history of breast cancer or an abnormal mammogram.

  
  

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Loestrin Fe 1/20 (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Loestrin Fe 1/20 (ethinyl estradiol and norethindrone)?

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Loestrin Fe 1/20 (ethinyl estradiol and norethindrone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

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  sudden numbness or weakness, especially on one side of the body;

  
  


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  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


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  sudden cough, wheezing, rapid breathing, coughing up blood;

  
  


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  pain, swelling, warmth, or redness in one or both legs;

  
  


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  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


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  a change in the pattern or severity of migraine headaches;

  
  


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  pain in your upper stomach, jaundice (yellowing of the skin or eyes);

  
  


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  a lump in your breast;

  
  


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  swelling in your hands, ankles, or feet; or

  
  


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  symptoms of depression (sleep problems, weakness, mood changes).

  
  

Less serious side effects may include:

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  mild nausea or vomiting, appetite or weight changes;

  
  


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  breast swelling or tenderness;

  
  


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  headache, nervousness, dizziness;

  
  


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  problems with contact lenses;

  
  


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  freckles or darkening of facial skin, loss of scalp hair; or

  
  


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  vaginal itching or discharge.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Loestrin Fe 1/20 (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

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  acetaminophen (Tylenol) or ascorbic acid (vitamin C);

  
  


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  bosentan (Tracleer);

  
  


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  prednisolone (Orapred);

  
  


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  St. John's wort;

  
  


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  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


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  an antibiotic;

  
  


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  HIV or AIDS medications;

  
  


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  phenobarbital (Solfoton) and other barbiturates; or

  
  


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  seizure medication.

  
  

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Loestrin Fe 1/20 resources

• Loestrin Fe 1/20 Side Effects (in more detail)
• Loestrin Fe 1/20 Use in Pregnancy & Breastfeeding
• Loestrin Fe 1/20 Drug Interactions
• Loestrin Fe 1/20 Support Group
• 2 Reviews for Loestrin Fe/20 - Add your own review/rating

• Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer)


• Aranelle Prescribing Information (FDA)


• Balziva Prescribing Information (FDA)


• Brevicon Prescribing Information (FDA)


• Briellyn Prescribing Information (FDA)


• Cyclafem 1/35 Prescribing Information (FDA)


• Cyclafem 7/7/7 Prescribing Information (FDA)


• Estrostep Fe Prescribing Information (FDA)


• Femcon FE Prescribing Information (FDA)


• Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Femhrt MedFacts Consumer Leaflet (Wolters Kluwer)


• Femhrt Consumer Overview


• Femhrt Prescribing Information (FDA)


• Jevantique Prescribing Information (FDA)


• Jinteli Prescribing Information (FDA)


• Leena Prescribing Information (FDA)


• Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer)


• Lo Loestrin Fe Consumer Overview


• Lo Loestrin Fe Prescribing Information (FDA)


• Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information


• Loestrin 24 FE Prescribing Information (FDA)


• Loestrin 24 Fe Consumer Overview


• Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer)


• Tilia FE Prescribing Information (FDA)


• Tri-Norinyl Prescribing Information (FDA)


• Zenchent FE Prescribing Information (FDA)


• Zeosa Prescribing Information (FDA)

Compare Loestrin Fe 1/20 with other medications

• Abnormal Uterine Bleeding
• Acne
• Birth Control
• Endometriosis
• Gonadotropin Inhibition
• Menstrual Disorders
• Polycystic Ovary Syndrome
• Postmenopausal Symptoms
• Prevention of Osteoporosis

Where can I get more information?

• Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Loestrin Fe/20 side effects (in more detail)

Piriton Tablets

1. Name Of The Medicinal Product

Piriton Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 4 milligrams of chlorphenamine maleate

Round, circular, biconvex, yellow tablets engraved with a 'P' to one side of the breakline, the reverse face being blank

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Piriton tablets are indicated for symptomatic control of all allergic conditions responsive to antihistamines, including hay fever, vasomotor rhinitis, urticaria, angioneurotic oedema, food allergy, drug and serum reactions, insect bites.

Also indicated for the symptomatic relief of itch associated with chickenpox.

4.2 Posology And Method Of Administration

Oral Administration only

Do no exceed the stated dose or frequency of dosing

Adults and children 12 years and over: 1 tablet 4 to 6 hourly. Maximum daily dose: 6 tablets (24 mg) in any 24 hours

Elderly: The elderly are more likely to experience neurological anticholinergic effects. Consideration should be given to using a lower daily dose (e.g. a maximum of 12 mg in any 24 hours).

Children aged 6 - 12 years: ½ tablet 4 to 6 hourly. Maximum daily dose: 3 tablets (12mg) in any 24 hours

Not recommended for children under 6 years

4.3 Contraindications

Piriton tablets are contra-indicated in patients who are hypersensitive to antihistamines or to any of the tablet ingredients.

The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs). Piriton Tablets is therefore contra-indicated in patients who have been treated with MAOIs within the last fourteen days.

4.4 Special Warnings And Precautions For Use

Chlorphenamine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intra-ocular pressure including glaucoma; prostatic hypertrophy; severe hypertension or cardiovascular disease; bronchitis, bronchiectasis or asthma; hepatic impairment. Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (eg. increased energy, restlessness, nervousness)

The effects of alcohol may be increased and therefore concurrent use should be avoided

Should not be used with other antihistamine containing products, including antihistamine containing cough and cold medicines

Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine,

Keep out of sight and reach of children

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concurrent use of chlorphenamine and hypnotics or anxiolytics may cause an increase in sedative effects, therefore medical advice should be sought before taking chlorphenamine concurrently with these medicines.

Chlorphenamine inhibits phenytoin metabolism and can lead to phenytoin toxicity.

The anticholinergic effects of chlorphenamine are intensified by MAOIs (see Contra-indications).

4.6 Pregnancy And Lactation

Pregnancy

There are no adequate data from the use of chlorphenamine maleate in pregnant women. The potentisl risk for humans is unknown. Use during the third trimester may result in reactions in the newborn or premature neonates. Not to be used during pregnancy unless considered essentially by a physician.

Lactation

Chlorphenamine maleate and other antihistamine may inhibit lactation and may be secreted in breast milk. Not to be used during lactation unless considered essential by a physician

4.7 Effects On Ability To Drive And Use Machines

The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patients' ability to drive and use machinery.

4.8 Undesirable Effects

Specific estimation of the frequency of adverse events for OTC products is inherently difficult (particularly numerator data). Adverse reactions which have been observed in clinical trails and which are considered to be common (occurring in

Blood and lymphatic system disorders:

Unknown: haemolytic anaemia, blood dyscrasias

Immune system disorders:

Unknown: allergic reaction, angioedema, anaphylactic reactions

Metabolism and nutritional disorders:

Unknown: anorexia

Psychiatric disorders:

Unknown: confusion*, excitation*, irritability*, nightmares*, depression

Nervous system disorders*:

Very common: sedation, somnolence

Common: disturbance in attention, abnormal coordination, dizziness headache

Eye Disorders:

Common: blurred vision

Ear and labyrinth disorders:

Unknown: tinnitus

Cardiac disorders:

Unknown: palpitations, tachycardia, arrythmias

Vascular disorders:

Unnown: Hypotension

Respiratory, thoracic and mediastinal disorders:

Unknown: thickening of bronchial secretions

Gastrointestinal disorders:

Common: nausea, dry mouth

Unknown: vomiting, abdominal pain, diarrhoea, dyspepsia

Hepatobiliary disorders:

Unknown: hepatitis, including jaundice

Skin and subcutaneous disorders:

Unknown: exfoliative dermatitis, rash, urticaria, photosensitivity

Musculoskeletal and connective tissue disorders:

Unknown: muscle twitching, muscle weakness

Renal and urinary disorders:

Unknown: urinary retention

General disorders and administration site conditions:

Common: fatigue

Unknown: chest tightness

*Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (eg. increased energy, restlessness, nervousness).

4.9 Overdose

Symptoms and signs

The estimated lethal dose of chlorphenamine is 25 to 50mg/kg body weight. Symptoms and signs include sedation, paradoxical excitation of the CNS, toxic psychosis, convulsions, apnoea, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.

Treatment

Symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance. If overdosage is by the oral route, treatment with activated charcoal should be considered provided there are no contraindications for use and the overdose has been taken recently (treatment is most effective if given within an hour of ingestion). Treat hypotension and arrhythmias vigorously. CNS convulsions may be treated with i.v. diazepam. Haemoperfusion may be used in severe cases.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code R06AB02

Chlorphenamine is a potent antihistamine (H1-antagonist).

Antihistamines diminish or abolish the actions of histamine in the body by competative reversible blockade of histamine H1-receptor sites on tissues. Chlorphenamine also has anticholinergic activity.

Antihistamines act to prevent the release of histamine, prostaglandins and leukotrines and have been shown to prevent the migration of inflammatory mediators. The actions of chlorphenmine include inhibition of histamine on smooth muscle, cappillary permeability and hence reduction of oedma and wheal in hypersneitivity reactions such as allergy and anaphylaxis.

5.2 Pharmacokinetic Properties

Chlorphenamine is well absorbed from the gastro-intestinal tract, following oral administration. The effects develop within 30 minutes, are maximal within 1 to 2 hours and last 4 to 6 hours. The plasma half-life has been estimated to be 12 to 15 hours.

Chlorphenamine is metabolised to the monodesmethyl and didesmethyl derivatives. About 22% of an oral dose is excreted unchanged in the urine.

5.3 Preclinical Safety Data

No additional data of relevance.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose

Maize Starch

Yellow Iron Oxide (E172)

Magnesium Stearate

Purified Water

6.2 Incompatibilities

None reported.

6.3 Shelf Life

4 years.

6.4 Special Precautions For Storage

Do not store above 30ºC

6.5 Nature And Contents Of Container

The tablets are supplied in securitainers containing 50 or 500 tablets or blister packs containing 30, 45, 60 or 100 tablets

6.6 Special Precautions For Disposal And Other Handling

For detailed instructions for use refer to the Patient Information Leaflet in every pack.

7. Marketing Authorisation Holder

Stafford Miller Limited

980 Great West Road

Brentford

Middlesex TW8 9GS

UNITED KINGDOM

Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, UK.

8. Marketing Authorisation Number(S)

PL 00036/0090

9. Date Of First Authorisation/Renewal Of The Authorisation

14 February 1997/28 April 2000

10. Date Of Revision Of The Text

24/05/2010

Norimin Tablets

1. Name Of The Medicinal Product

Norimin.

2. Qualitative And Quantitative Composition

Each tablet contains 1 milligram norethisterone and 35 micrograms ethinylestradiol.

3. Pharmaceutical Form

White round flat tablets with bevel-edged tablet inscribed 'SEARLE' on one side and 'BX' on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Norimin is indicated for oral contraception, with the benefit of a low intake of oestrogen.

4.2 Posology And Method Of Administration

Oral Administration: The dosage of Norimin for the initial cycle of therapy is 1 tablet taken at the same time each day from the first day of the menstrual cycle. For subsequent cycles, no tablets are taken for 7 days, then a new course is started of 1 tablet daily for the next 21 days. This sequence of 21 days on treatment, seven days off treatment is repeated for as long as contraception is required.

Patients unable to start taking Norimin tablets on the first day of the menstrual cycle may start treatment on any day up to and including the 5th day of the menstrual cycle.

Patients starting on day 1 of their period will be protected at once. Those patients delaying therapy up to day 5 may not be protected immediately and it is recommended that another method of contraception is used for the first 7 days of tablet-taking. Suitable methods are condoms, caps plus spermicides and intra-uterine devices. The rhythm, temperature and cervical-mucus methods should not be relied upon.

Tablet omissions

Tablets must be taken daily in order to maintain adequate hormone levels and contraceptive efficacy.

If a tablet is missed within 12 hours of the correct dosage time then the missed tablet should be taken as soon as possible, even if this means taking 2 tablets on the same day, this will ensure that contraceptive protection is maintained. If one or more tablets are missed for more than 12 hours from the correct dosage time it is recommended that the patient takes the last missed tablet as soon as possible and then continues to take the rest of the tablets in the normal manner. In addition, it is recommended that extra contraceptive protection, such as a condom, is used for the next 7 days.

Patients who have missed one or more of the last 7 tablets in a pack should be advised to start the next pack of tablets as soon as the present one has finished (i.e. without the normal seven day gap between treatments). This reduces the risk of contraceptive failure resulting from tablets being missed close to a 7 day tablet free period.

Changing from another oral contraceptive

In order to ensure that contraception is maintained it is advised that the first dose of Norimin tablets is taken on the day immediately after the patient has finished the previous pack of tablets.

Use after childbirth, miscarriage or abortion

Providing the patient is not breast feeding the first dose of Norimin tablets should be taken on the 21st day after childbirth. This will ensure the patient is protected immediately. If there is any delay in taking the first dose, contraception may not be established until 7 days after the first tablet has been taken. In these circumstances patients should be advised that extra contraceptive methods will be necessary.

After a miscarriage or abortion patients can take the first dose of Norimin tablets on the next day; in this way they will be protected immediately.

4.3 Contraindications

As with all combined progestogen/oestrogen oral contraceptives, the following conditions should be regarded as contra-indications:

i. History of confirmed venous thromboembolic disease (VTE), family history of idiopathic VTE and other known risk factors of VTE

ii. Thrombophlebitis, cerebrovascular disorders, coronary artery disease, myocardial infarction, angina, hyperlipidaemia or a history of these conditions.

iii. Acute or severe chronic liver disease, including liver tumours, Dubin-Johnson or Rotor syndrome.

iv. History during pregnancy of idiopathic jaundice, severe pruritus or pemphigoid gestationis.

v. Known or suspected breast or genital cancer.

vi. Known or suspected oestrogen-dependent neoplasia.

vii. Undiagnosed abnormal vaginal bleeding.

viii. A history of migraines classified as classical focal or crescendo.

ix. Pregnancy.

4.4 Special Warnings And Precautions For Use

Assessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. Physical examination should be guided by this and by the contraindications (section 4.3) and warnings (section 4.4) for this product. The frequency and nature of these assessments should be based upon relevant guidelines and should be adapted to the individual woman, but should include measurement of blood pressure and, if judged appropriate by the clinician, breast, abdominal and pelvic examination including cervical cytology.

Women taking oral contraceptives require careful observation if they have or have had any of the following conditions: breast nodules; fibrocystic disease of the breast or an abnormal mammogram; uterine fibroids; a history of severe depressive states; varicose veins; sickle-cell anaemia; diabetes; hypertension; cardiovascular disease; migraine; epilepsy; asthma; otosclerosis; multiple sclerosis; porphyria; tetany; disturbed liver functions; gallstones; kidney disease; chloasma; any condition that is likely to worsen during pregnancy. The worsening or first appearance of any of these conditions may indicate that the oral contraceptive should be stopped. Discontinue treatment if there is a gradual or sudden, partial or complete loss of vision or any evidence of ocular changes, onset or aggravation of migraine or development of headache of a new kind which is recurrent, persistent or severe.

Gastro-intestinal upsets, such as vomiting and diarrhoea, may interfere with the absorption of the tablets leading to a reduction in contraceptive efficacy. Patients should continue to take Norimin, but they should also be encouraged to use another contraceptive method during the period of gastro-intestinal upset and for the next 7 days.

Progestogen oestrogen preparations should be used with caution in patients with a history of hepatic dysfunction or hypertension.

An increased risk of venous thromboembolic disease (VTE) associated with the use of oral contraceptives is well established but is smaller than that associated with pregnancy, which has been estimated at 60 cases per 100,000 pregnancies. Some epidemiological studies have reported a greater risk of VTE for women using combined oral contraceptives containing desogestrel or gestodene (the so-called 'third generation' pills) than for women using pills containing levonorgestrel or norethisterone (the so-called 'second generation' pills

The spontaneous incidence of VTE in healthy non-pregnant women (not taking any oral contraceptive) is about 5 cases per 100,000 per year. The incidence in users of second generation pills is about 15 per 100,000 women per year of use. The incidence in users of third generation pills is about 25 cases per 100,000 women per year of use; this excess incidence has not been satisfactorily explained by bias or confounding. The level of all of these risks of VTE increases with age and is likely to be further increased in women with other known risk factors for VTE such as obesity. The excess risk of VTE is highest during the first year a woman ever uses a combined oral contraceptive.

Patients receiving oral contraceptives should be kept under regular surveillance, in view of the possibility of developments such as thromboembolism.

The risk of coronary artery disease in women taking oral contraceptives is increased by the presence of other predisposing factors such as cigarette smoking, hypercholesterolaemia, obesity, diabetes, history of pre-eclamptic toxaemia and increasing age. After the age of thirty-five years, the patient and physician should carefully re-assess the risk/benefit ratio of using combined oral contraceptives as opposed to alternative methods of contraception.

Norimin should be discontinued at least four weeks before, and for two weeks following, elective operations and during immobilisation. Patients undergoing injection treatment for varicose veins should not resume taking Norimin until 3 months after the last injection.

Benign and malignant liver tumours have been associated with oral contraceptive use. The relationship between occurrence of liver tumours and use of female sex hormones is not known at present. These tumours may rupture causing intra-abdominal bleeding. If the patient presents with a mass or tenderness in the right upper quadrant or an acute abdomen, the possible presence of a tumour should be considered.

An increased risk of congenital abnormalities, including heart defects and limb defects, has been reported following the use of sex hormones, including oral contraceptives, in pregnancy. If the patient does not adhere to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and further use of oral contraceptives should be withheld until pregnancy has been ruled out. It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen. If pregnancy is confirmed the patient should be advised of the potential risks to the foetus and the advisability of continuing the pregnancy should be discussed in the light of these risks. It is advisable to discontinue Norimin three months before a planned pregnancy.

The risk of arterial thrombosis associated with combined oral contraceptives increases with age, and this risk is aggravated by cigarette smoking. The use of combined oral contraceptives by women in the older age group, especially those who are cigarette smokers, should therefore be discouraged and alternative methods advised.

The use of this product in patients suffering from epilepsy, migraine, asthma or cardiac dysfunction may result in exacerbation of these disorders because of fluid retention. Caution should also be observed in patients who wear contact lenses.

Decreased glucose tolerance may occur in diabetic patients on this treatment, and their control must be carefully supervised.

The use of oral contraceptives has also been associated with a possible increased incidence of gall bladder disease.

Women with a history of oligomenorrhoea or secondary amenorrhoea or young women without regular cycles may have a tendency to remain anovulatory or to become amenorrhoeic after discontinuation of oral contraceptives. Women with these pre-existing problems should be advised of this possibility and encouraged to use other contraceptive methods.

Numerous epidemiological studies have been reported on the risks of ovarian, endometrial, cervical and breast cancer in women using combined oral contraceptives. The evidence is clear that combined oral contraceptives offer substantial protection against both ovarian and endometrial cancer.

An increased risk of cervical cancer in long-term users of combined oral contraceptives has been reported in some studies, but there continues to be controversy about the extent to which this is attributable to the confounding effects of sexual behaviour and other factors.

A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using combined oral contraceptives (COCs). The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in COC users, the biological effects of COCs or a combination of both. The additional breast cancers diagnosed in current users of COCs or in women who have used COCs in the last ten years are more likely to be localised to the breast than those in women who never used COCs.

Breast cancer is rare among women under 40 years of age whether or not they take COCs. Whilst this background risk increases with age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer (see bar chart).

The most important risk factor for breast cancer in COC users is the age women discontinue the COC; the older the age at stopping, the more breast cancers are diagnosed. Duration of use is less important and the excess risk gradually disappears during the course of the 10 years after stopping COC use such that by 10 years there appears to be no excess.

The possible increase in risk of breast cancer should be discussed with the user and weighed against the benefits of COCs taking into account the evidence that they offer substantial protection against the risk of developing certain other cancers (e.g. ovarian and endometrial cancer).

Estimated cumulative numbers of breast cancers per 10,000

women diagnosed in 5 years of use and up to 10 years after

stopping COCs, compared with numbers of breast

cancers diagnosed in 10,000 women who had

never used COCs.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The herbal remedy St John's wort (Hypericum perforatum) should not be taken concomitantly with this medicine as this could potentially lead to a loss of contraceptive effect.

Some drugs may modify the metabolism of Norimin reducing its effectiveness; these include certain sedatives, antibiotics, anti-epileptic and anti-arthritic drugs. During the time such agents are used concurrently, it is advised that mechanical contraceptives also be used.

The results of a large number of laboratory tests have been shown to be influenced by the use of oestrogen containing oral contraceptives, which may limit their diagnostic value. Among these are: biochemical markers of thyroid and liver function; plasma levels of carrier proteins, triglycerides, coagulation and fibrinolysis factors.

4.6 Pregnancy And Lactation

Contra-indicated in pregnancy.

Patients who are fully breast-feeding should not take Norimin tablets since, in common with other combined oral contraceptives, the oestrogen component may reduce the amount of milk produced. In addition, active ingredients or their metabolites have been detected in the milk of mothers taking oral contraceptives. The effect of Norimin on breast-fed infants has not been determined.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

As with all oral contraceptives, there may be slight nausea at first, weight gain or breast discomfort, which soon disappear.

Other side-effects known or suspected to occur with oral contraceptives include gastro-intestinal symptoms, changes in libido and appetite, headache, exacerbation of existing uterine fibroid disease, depression, and changes in carbohydrate, lipid and vitamin metabolism.

Spotting or bleeding may occur during the first few cycles. Usually menstrual bleeding becomes light and occasionally there may be no bleeding during the tablet-free days.

Hypertension, which is usually reversible on discontinuing treatment, has occurred in a small percentage of women taking oral contraceptives.

4.9 Overdose

Overdosage may be manifested by nausea, vomiting, breast enlargement and vaginal bleeding. There is no specific antidote and treatment should be symptomatic. Gastric lavage may be employed if the overdose is large and the patient is seen sufficiently early (within four hours).

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The mode of action of Norimin is similar to that of other progestogen/oestrogen oral contraceptives and includes the inhibition of ovulation, the thickening of cervical mucus so as to constitute a barrier to sperm and the rendering of the endometrium unreceptive to implantation. Such activity is exerted through a combined effect on one or more of the following: hypothalamus, anterior pituitary, ovary, endometrium and cervical mucus.

5.2 Pharmacokinetic Properties

Norethisterone is rapidly and completely absorbed after oral administration, peak plasma concentrations occurring in the majority of subjects between 1 and 3 hours. Due to first-pass metabolism, blood levels after oral administration are 60% of those after i.v. administration. The half life of elimination varies from 5 to 12 hours, with a mean of 7.6 hours. Norethisterone is metabolised mainly in the liver. Approximately 60% of the administered dose is excreted as metabolites in urine and faeces.

Ethinylestradiol is rapidly and well absorbed from the gastro-intestinal tract but is subject to some first-pass metabolism in the gut-wall. Compared to many other oestrogens it is only slowly metabolised in the liver. Excretion is via the kidneys with some appearing also in the faeces.

5.3 Preclinical Safety Data

The toxicity of norethisterone is very low. Reports of teratogenic effects in animals are uncommon. No carcinogenic effects have been found even in long-term studies.

Long-term continuous administration of oestrogens in some animals increases the frequency of carcinoma of the breast, cervix, vagina and liver.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Norimin tablets contain:

Maize starch, polyvidone, magnesium stearate and lactose.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

The shelf life of Norimin tablets is 5 years.

6.4 Special Precautions For Storage

Store in a dry place, below 25^oC, away from direct sunlight.

6.5 Nature And Contents Of Container

Norimin tablets are supplied in pvc/foil blister packs of 21 and 63 tablets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Pharmacia Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ, UK

8. Marketing Authorisation Number(S)

PL 00032/0411.

9. Date Of First Authorisation/Renewal Of The Authorisation

8 July 2002

10. Date Of Revision Of The Text

June 2007

NM 2_0

PeriGuard

Generic Name: zinc oxide topical (ZINK OX ide)

Brand Names: ARC, Balmex, Boudreaux Butt Paste, Caldesene, Calmol-4 Suppository, Critic-Aid Skin Paste, Delazinc, Dermagran BC, Desitin, Desitin Maximum Strength Original, Desitin Rapid Relief Creamy, Diaper Rash Ointment, Diaper Relief, Dr. Smith's Diaper, Flanders Buttocks Ointment, Geri-Protect, Medi-Paste, PeriGuard, Pinxav, Rash Relief, RVPaque, Seniortopix Healix, Soothe & Cool Skin Paste, Sportz Block Dark, Sportz Block Light, Sportz Block Medium, Triple Paste, Tronolane Suppositories, Unna-Flex Elastic Unna Boot 3 inch, Unna-Flex Elastic Unna Boot 4 inch, Znlin

What is PeriGuard (zinc oxide topical)?

Zinc oxide is a mineral.

Zinc oxide topical (for the skin) is used to treat diaper rash, minor burns, severely chapped skin, or other minor skin irritations.

Zinc oxide rectal suppositories are used to treat itching, burning, irritation, and other rectal discomfort caused by hemorrhoids or painful bowel movements.

Zinc oxide topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about PeriGuard (zinc oxide topical)?

You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.

Avoid using other medications on the areas you treat with zinc oxide unless you doctor tells you to.

What should I discuss with my health care provider before using PeriGuard (zinc oxide topical)?

You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

It is not known whether zinc oxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether zinc oxide topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby.

How should I use PeriGuard (zinc oxide topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Apply enough of this medication to cover the entire area to be treated. Zinc oxide often leaves a thin white residue that may not be entirely rubbed in.

To treat chapped skin, minor burn wounds, or other skin irritations, use the medication as often as needed. Apply a thin layer to the affected area and rub in gently.

To treat diaper rash, use this medication each time the diaper is changed. It is especially important to apply the medication at bedtime or whenever there will be a long period of time between diaper changes.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

When using the powder form of this medicine, pour the powder slowly to avoid a large puff into the air. Do not allow a baby to handle a powder bottle during use. Always close the lid after using the powder.

Zinc oxide rectal suppositories come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after inserting a rectal suppository.

Try to empty your bowel and bladder just before using the suppository. Cleanse and dry your rectal area thoroughly.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results, stay lying down after inserting the suppository and hold it in your rectum for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Store at room temperature away from moisture and heat. Keep the tube cap tightly closed when not in use. You may store zinc oxide rectal suppositories in a refrigerator to prevent melting.

What happens if I miss a dose?

Since zinc oxide is used on an as needed basis, you are not likely to miss a dose. Using extra zinc oxide to make up a missed dose will not make the medication more effective.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using PeriGuard (zinc oxide topical)?

Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.

PeriGuard (zinc oxide topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using zinc oxide rectal suppositories if you have rectal bleeding or continued pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect PeriGuard (zinc oxide topical)?

Avoid applying other skin medications on the same treatment area with zinc oxide, unless your doctor has told you to.

There may be other drugs that can interact with zinc oxide topical or rectal suppositories. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More PeriGuard resources

• PeriGuard Side Effects (in more detail)
• PeriGuard Use in Pregnancy & Breastfeeding
• PeriGuard Support Group
• 0 Reviews for PeriGuard - Add your own review/rating

• Arcalyst Monograph (AHFS DI)


• Caldesene Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Desitin Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare PeriGuard with other medications

• Anal Itching
• Dermatologic Lesion

Where can I get more information?

• Your pharmacist can provide more information about zinc oxide topical.

See also: PeriGuard side effects (in more detail)

Sul-Ray Aloe Vera Acne Topical

Generic Name: sulfur (Topical route)

SUL-fur

Commonly used brand name(s)

In the U.S.

• Liquimat


• Sastid Soap


• Sulfoam


• Sulfo-Lo


• Sulmasque


• Sulpho-Lac


• Sul-Ray Aloe Vera Acne


• Thylox Acne Treatment


• Zapzyt Cleansing

Available Dosage Forms:

• Soap


• Ointment


• Shampoo


• Liquid


• Lotion


• Cream


• Gel/Jelly


• Solution

Therapeutic Class: Antiacne

Uses For Sul-Ray Aloe Vera Acne

Sulfur is used to treat many kinds of skin disorders. Sulfur cream, lotion, ointment, and bar soap are used to treat acne. Sulfur ointment is used to treat seborrheic dermatitis and scabies. Sulfur may also be used for other conditions as determined by your doctor.

Some of these preparations are available only with your doctor's prescription.

Before Using Sul-Ray Aloe Vera Acne

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of this medicine in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing use of sulfur in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of sulfur

This section provides information on the proper use of a number of products that contain sulfur. It may not be specific to Sul-Ray Aloe Vera Acne. Please read with care.

Use this medicine only as directed. Do not use it more often and do not use it for a longer period of time than recommended on the label, unless otherwise directed by your doctor.

Keep this medicine away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water.

To use the cream or lotion form of this medicine:

• Before applying the medicine, wash the affected areas with soap and water and dry thoroughly. Then apply enough medicine to cover the affected areas and rub in gently.

To use the ointment form of this medicine for seborrheic dermatitis:

• Before applying the medicine, wash the affected areas with soap and water and dry thoroughly. Then apply enough medicine to cover the affected areas and rub in gently.

To use the ointment form of this medicine for scabies:

• Before applying the medicine, wash your entire body with soap and water and dry thoroughly.


• At bedtime, apply enough medicine to cover your entire body from the neck down and rub in gently. Leave the medicine on your body for 24 hours.


• Before applying the medicine again, you may wash your entire body.


• 24 hours after the last treatment with this medicine, it is important that you thoroughly wash your entire body again.

To use the soap form of this medicine:

• Work up a rich lather with the soap, using warm water. Wash the affected areas and rinse thoroughly. Apply again, and rub in gently for a few minutes. Remove excess lather with a towel or tissue without rinsing.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For acne:
  
  • For cream and bar soap dosage forms:
    
    • Adults and children—Use on the skin as needed.
    
    
  
  
  • For lotion dosage form:
    
    • Adults and children—Use two or three times a day.
    
    
  
  
  • For ointment dosage form:
    
    • Adults and children—Use the 0.5% ointment on the skin as needed.
    
    
  
  


• For seborrheic dermatitis:
  
  • For ointment dosage form:
    
    • Adults and children—Use the 5 to 10% ointment one or two times a day.
    
    
  
  


• For scabies:
  
  • For ointment dosage form:
    
    • Adults and children—Use the 6% ointment each night for three nights.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Sul-Ray Aloe Vera Acne

When using sulfur, do not use any of the following preparations on the same affected area as this medicine, unless otherwise directed by your doctor:

• Abrasive soaps or cleansers


• Alcohol-containing preparations


• Any other topical acne preparation or preparation containing a peeling agent (for example, benzoyl peroxide, resorcinol, salicylic acid, or tretinoin [vitamin A acid])


• Cosmetics or soaps that dry the skin


• Medicated cosmetics


• Other topical medicine for the skin

To use any of the above preparations on the same affected area as sulfur may cause severe irritation of the skin.

Do not use any topical mercury-containing preparation, such as ammoniated mercury ointment, on the same area as this medicine. To do so may cause a foul odor, may be irritating to the skin, and may stain the skin black. If you have any questions about this, check with your health care professional.

Sul-Ray Aloe Vera Acne Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Skin irritation not present before use of this medicine

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Redness and peeling of skin (may occur after a few days)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Sul-Ray Aloe Vera Acne Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Sul-Ray Aloe Vera Acne Topical resources

• Sul-Ray Aloe Vera Acne Topical Side Effects (in more detail)
• Sul-Ray Aloe Vera Acne Topical Use in Pregnancy & Breastfeeding
• Sul-Ray Aloe Vera Acne Topical Drug Interactions
• Sul-Ray Aloe Vera Acne Topical Support Group
• 1 Review for Sul-Ray Aloe Vera Acne Topical - Add your own review/rating

Compare Sul-Ray Aloe Vera Acne Topical with other medications

• Acne

Piperacillin

Pronunciation: PI-per-a-SIL-in
Generic Name: Piperacillin
Brand Name: Generic only. No brands available.

Piperacillin is used for:

Treating serious bacterial infections. It may also be used to prevent infections during surgery.

Piperacillin is an antibacterial agent. It works by blocking the bacteria's cell wall growth, which kills the bacteria.

Do NOT use Piperacillin if:

• you are allergic to any ingredient in Piperacillin


• you have a history of allergic reaction to any penicillin (eg, amoxicillin), cephalosporin (eg, cephalexin), or beta-lactam antibiotic (eg, imipenem)


• you are taking a tetracycline antibiotic (eg, doxycycline)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Piperacillin:

Some medical conditions may interact with Piperacillin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have cystic fibrosis, bowel inflammation, bleeding problems, congestive heart failure, or kidney problems


• if you are on dialysis, or if you have a history of severe diarrhea or bowel problems due to an antibiotic


• if you are on a salt-restricted diet or have low blood potassium levels

Some MEDICINES MAY INTERACT with Piperacillin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aminoglycosides (eg, tobramycin) or oral contraceptives (birth control pills) because their effectiveness may be decreased by Piperacillin


• Anticoagulants (eg, warfarin) because their effectiveness may be decreased or the risk of their side effects may be increased by Piperacillin


• Chemotherapy or diuretics (eg, furosemide, hydrochlorothiazide) because the risk of side effects, such as low blood potassium levels, may be increased


• Heparin, methotrexate, or nondepolarizing muscle relaxants (eg, vecuronium) because their actions and the risk of their side effects may be increased by Piperacillin


• Tetracyclines (eg, doxycycline) because they may decrease Piperacillin's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Piperacillin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Piperacillin:

Use Piperacillin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Piperacillin is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Piperacillin at home, a health care provider will teach you how to use it. Be sure you understand how to use Piperacillin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Piperacillin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Piperacillin, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Piperacillin.

Important safety information:

• Piperacillin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Piperacillin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Piperacillin. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Piperacillin may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea, (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Tell your doctor or dentist that you take Piperacillin before you receive any medical or dental care, emergency care, or surgery.


• Piperacillin only works against bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to use Piperacillin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Piperacillin may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Diabetes patients - Piperacillin may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.


• Piperacillin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Piperacillin.


• Lab tests, including blood electrolyte levels, kidney or liver function, and complete blood cell counts, may be performed while you use Piperacillin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Piperacillin with caution in the ELDERLY; they may be more sensitive to its effects.


• Piperacillin should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Piperacillin while you are pregnant. Piperacillin is found in breast milk. If you are or will be breast-feeding while you use Piperacillin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Piperacillin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; loose stools; nausea; pain, swelling, or redness at the injection site; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; calf pain or tenderness; decreased urination; fever, chills, or sore throat; inflammation at injection site; prolonged muscle relaxation; red, swollen, or blistered skin; seizures; severe diarrhea, vomiting, or stomach pain; unusual bruising or bleeding; unusual tiredness or weakness; vaginal irritation or discharge; vein inflammation or tenderness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Piperacillin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org ), or emergency room immediately. Symptoms may include excitability; seizures.

Proper storage of Piperacillin:

Piperacillin is usually handled and stored by a health care provider. If you are using Piperacillin at home, store Piperacillin as directed by your pharmacist or health care provider.

General information:

• If you have any questions about Piperacillin, please talk with your doctor, pharmacist, or other health care provider.


• Piperacillin is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Piperacillin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Piperacillin resources

• Piperacillin Side Effects (in more detail)
• Piperacillin Use in Pregnancy & Breastfeeding
• Piperacillin Drug Interactions
• Piperacillin Support Group
• 0 Reviews for Piperacillin - Add your own review/rating

• Piperacillin Sodium and Tazobactam Sodium Monograph (AHFS DI)


• Pipracil Prescribing Information (FDA)


• Pipracil Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Piperacillin with other medications

• Bone infection
• Cesarean Section
• Febrile Neutropenia
• Gonococcal Infection, Uncomplicated
• Hysterectomy
• Intraabdominal Infection
• Joint Infection
• Kidney Infections
• Meningitis
• Nosocomial Pneumonia
• Pelvic Inflammatory Disease
• Peritonitis
• Pneumonia
• Pneumonia with Cystic Fibrosis
• Septicemia
• Skin Infection
• Surgical Prophylaxis
• Urinary Tract Infection

Frovatriptan Succinate

Class: Selective Serotonin Agonists
VA Class: CN105
Chemical Name: (+)-(R)-2,3,4,9-tetrahydro-3-(methylamino)-1H-carbazole-6-carboxamide butanedioate monohydrate
Molecular Formula: C₁₄H₁₇N₃O•H₂O
CAS Number: 158930-17-7
Brands: Frova

Introduction

Selective serotonin (5-hydroxytryptamine; 5-HT) type 1B and 1D receptor agonist (“triptan”).^{1 2}

Uses for Frovatriptan Succinate

Vascular Headaches

Acute treatment of migraine attacks with or without aura.^{1 4 5}

Not recommended for management of hemiplegic or basilar migraine or for prophylaxis of migraine.¹

Safety and efficacy not established for management of cluster headaches.¹

Frovatriptan Succinate Dosage and Administration

Administration

Oral Administration

Administer orally with fluids without regard to meals.¹

Dosage

Available as frovatriptan succinate; dosage is expressed in terms of frovatriptan.¹

Adults

Vascular Headaches

Migraine

Oral

2.5 mg as a single dose.¹ Higher dosages provide no additional benefit but may increase risk of adverse effects.^{1 2}

If headache recurs, additional doses may be administered at intervals of ≥2 hours, up to a maximum dosage of 7.5 mg in any 24-hour period.¹

If patient does not respond to first dose, additional doses are unlikely to provide benefit for the same headache.¹

Prescribing Limits

Adults

Vascular Headaches

Migraine

Oral

Maximum 7.5 mg in any 24-hour period.¹

Safety of treating an average of >4 headaches per 30-day period has not been established.¹

Special Populations

Hepatic Impairment

No dosage adjustment required in patients with mild to moderate hepatic impairment; not studied in patients with severe hepatic impairment.¹

Cautions for Frovatriptan Succinate

Contraindications

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  Known or suspected ischemic heart disease (e.g., angina pectoris, history of MI, documented silent ischemia).¹

  
  


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  Coronary artery vasospasm (e.g., Prinzmetal variant angina).¹

  
  


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  Other serious underlying cardiovascular disease (e.g., uncontrolled hypertension).¹

  
  


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  Cerebrovascular syndromes (e.g., stroke syndrome, TIAs).¹

  
  


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  Peripheral vascular ischemia (e.g., ischemic bowel disease).¹

  
  


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  Hemiplegic or basilar migraine.¹

  
  


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  Treatment within previous 24 hours with another 5-HT₁ receptor agaonist or an ergot alkaloid.¹ (See Specific Drugs under Interactions.)

  
  


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  Known hypersensitivity to frovatriptan or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Use only in patients in whom a clear diagnosis of migraine has been established.¹

If first migraine attack treated with frovatriptan fails to respond to the drug, reconsider diagnosis before administering frovatriptan to treat subsequent attacks.¹

Cardiac Effects

Risk of myocardial ischemia and/or infarction, coronary vasospasm, life-threatening cardiac rhythm disturbances, and death with use of 5-HT₁ receptor agonists.¹

Use not recommended in patients with known or suspected ischemic or vasospastic heart disease or in patients in whom unrecognized CAD is likely (e.g., postmenopausal women; men >40 years of age; patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, diabetes, or family history of CAD) unless there is satisfactory evidence from prior cardiovascular evaluation that patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.¹

Administer initial dose to patients with risk factors for CAD who have completed satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician’s office, possibly followed by ECG) unless patient previously received the drug.¹

Periodic cardiovascular evaluation recommended in patients with risk factors for CAD if receiving intermittent long-term therapy.¹

Patients with symptoms suggestive of angina after receiving frovatriptan should be evaluated for presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses.¹

Cerebrovascular Events

Possible cerebral or subarachnoid hemorrhage, stroke, and other cerebrovascular events, sometimes fatal, with use of 5-HT₁ receptor agonists.¹

Risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA) may be increased in patients with migraine.¹

Other Cardiovascular or Vasospastic Effects

Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea reported with use of 5-HT₁ receptor agonists.¹ Further evaluation recommended if signs or symptoms of decreased arterial flow (e.g., ischemic colitis, Raynaud’s phenomenon) occur following administration.^{1 6 8}

Substantial increases in BP, including hypertensive crises, reported rarely with 5-HT₁ receptor agonists in patients with or without history of hypertension;^{1 6} transient increases in BP observed following administration of recommended dosage of frovatriptan (2.5 mg) in geriatric patients.¹

Increases in mean pulmonary artery pressure observed following administration of a 5-HT₁ receptor agonist to patients with suspected CAD who were undergoing cardiac catheterization.¹

Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with 5-HT₁ receptor agonists (“triptans”) and SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs).^{1 11} Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).¹¹ (See Specific Drugs under Interactions.)

General Precautions

Ocular Effects

Possible accumulation of frovatriptan and/or its metabolites in melanin-rich tissues (e.g., eye) over time, resulting in potential toxicity in these tissues with extended use.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Distributed into milk in rats; not known whether distributed into milk in humans.¹ Caution advised if frovatriptan is used.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age; use not recommended.¹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults.¹ (See Special Populations under Pharmacokinetics.)

Hepatic Impairment

Use with caution in patients with mild to moderate hepatic impairment.^{8 9} (See Special Populations under Pharmacokinetics.)

Not studied in patients with severe hepatic impairment.¹

Common Adverse Effects

Dizziness,¹ fatigue,¹ headache,¹ paresthesia,¹ flushing,¹ dry mouth,¹ hot or cold sensation,¹ skeletal pain,¹ dyspepsia,¹ chest pain,¹ somnolence,¹ nausea.¹

Interactions for Frovatriptan Succinate

Appears to be metabolized principally via CYP1A2.^{1 3 10}

Does not inhibit CYP1A2, 2C9, 2C19, 2D6, 2E1, or 3A4 or MAO isoenzymes in vitro; does not induce drug metabolizing enzymes.¹ Pharmacokinetic interaction with drugs metabolized by these isoenzymes unlikely.^{1 9}

Drugs Affecting Hepatic Microsomal Enzymes

Potential pharmacokinetic interaction (increased plasma frovatriptan concentrations) with concomitant use of CYP1A2 inhibitors; however, effects not considered clinically relevant.^{8 10}

Specific Drugs

Drug	Interaction	Comments
Antidepressants, SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) or SNRIs (e.g., duloxetine, venlafaxine)	Potentially life-threatening serotonin syndrome1 11 Potential increase in blood frovatriptan concentrations with concomitant fluvoxamine administration10	Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated1 11 No dosage adjustment required if fluvoxamine is used concomitantly8 10
Ergot alkaloids (e.g., ergotamine, dihydroergotamine, methysergide)	Additive vasospastic effects1	Use within 24 hours contraindicated1
5-HT1 receptor agonists	Additive vasospastic effects1	Use within 24 hours contraindicated1
Oral contraceptives	Possible increased plasma concentrations of frovatriptan8 9	No dosage adjustment required8 9
Propranolol	Possible increased plasma concentrations of frovatriptan1 3 10	No dosage adjustment required8 10

Frovatriptan Succinate Pharmacokinetics

Absorption

Bioavailability

Incompletely absorbed from GI tract; absolute bioavailability of 20 and 30% in males and females, respectively.^{1 9}

Peak plasma concentrations attained approximately 2–4 hours after oral administration.^{1 9}

Food

Food does not affect bioavailability but may delay time to peak plasma concentration by 1 hour.¹

Distribution

Extent

Distributes into cellular fraction of blood, principally erythrocytes (approximately 60% reversibly bound).⁹

Animal studies indicate limited capacity to cross blood-brain barrier.⁹

Distributed into milk in rats; not known whether distributed into milk in humans.¹

Plasma Protein Binding

Approximately 15%.^{1 9}

Elimination

Metabolism

Appears to be metabolized principally via CYP1A2 to numerous metabolites, including desmethyl frovatriptan, which exhibits lower affinity for 5-HT_1B/1D receptors compared with frovatriptan.^{1 3}

Elimination Route

Excreted in urine (32%) and feces (62%) as unchanged drug and metabolites.¹

Half-life

Approximately 26 hours.^{1 9}

Special Populations

In patient with mild to moderate hepatic impairment, AUC is twofold higher than in healthy individuals; pharmacokinetics not studied in patients with severe hepatic impairment.¹

In geriatric patients, AUC is 1.5- to 2-fold higher than in younger adults; half-life and time to peak plasma concentrations unchanged.¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹ Protect from moisture and light.¹

ActionsActions

• 
  

  Binds with high affinity to 5-HT_1B and 5-HT_1D receptors.¹

  
  


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  Structurally distinct from, but pharmacologically related to, other selective 5-HT_1B/1D receptor agonists (e.g., almotriptan, eletriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan).^{2 7 8}

  
  


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  Precise mechanism of action not established;⁶ may ameliorate migraine through selective constriction of certain intracranial blood vessels, inhibition of neuropeptide release, and reduced transmission in trigeminal pain pathway.^{1 2}

  
  

Advice to Patients

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  Importance of immediately informing clinician if tightness, pain, pressure, or heaviness in chest, throat, jaw, or neck occurs¹ and of not taking frovatriptan again until evaluated by clinician.⁸

  
  


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  Importance of taking frovatriptan exactly as prescribed.¹

  
  


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  Importance of providing patient a copy of manufacturer’s patient information.¹

  
  


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  Risk of dizziness or fatigue; importance of exercising caution when driving or operating machinery.¹

  
  


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  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease).¹

  
  


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  Importance of informing patients of risk of serotonin syndrome with concurrent use of frovatriptan and an SSRI or SNRI.^{1 11} Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.¹¹

  
  


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  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


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  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Frovatriptan Succinate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	2.5 mg (of frovatriptan)	Frova	Endo

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Frova 2.5MG Tablets (ENDO PHARMACEUTICALS): 9/$241.99 or 27/$699.93

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions May 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Endo Pharmaceuticals Inc. Frova (frovatriptan succinate) tablets prescribing information. Chadds Ford, PA; 2006 Jun.

2. Tfelt-Hansen P, De Vries P, Saxena PR. Triptans in migraine: a comparative review of pharmacology, pharmacokinetics, and efficacy. Drugs. 2000; 60:1259-87. [PubMed 11152011]

3. Jhee SS, Shiovitz T, Crawford AW et al. Pharmacokinetics and pharmacodynamics of the triptan antimigraine agents: a comparative review. Clin Pharmacokinet. 2001; 40:189-205. [PubMed 11327198]

4. Matchar DB, Young WB, Rosenberg JH et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management of acute attacks. From American Academy of Neurology web site ().

5. Silberstein SD, for the US Headache Consortium. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the quality standards subcommittee of the American Academy of Neurology. Neurology. 2000; 55:754-63. [IDIS 453389] [PubMed 10993991]

6. GlaxoWellcome. Amerge (naratriptan hydrochloride) tablets prescribing information. Research Triangle Park, NC; 1999 Nov.

7. Deleu D, Hanssens Y. Current and emerging second-generation triptans in acute migraine therapy: a comparative review. J Clin Pharmacol. 2000; 40:687-700. [IDIS 449430] [PubMed 10883409]

8. Elan Pharmaceuticals, South San Francisco, CA: Personal communication.

9. Buchan P, Keywood C, Wade A et al. Clinical pharmacokinetics of frovatriptan. Headache. 2002; 42(Suppl 2):S54-62.

10. Buchan P, Wade A, Ward C et al. Frovatriptan: a review of drug-drug interactions. Headache. 2002; 42(Suppl 2):S63-73.

11. Food and Drug Administration. Public health advisory: combined use of 5-hydroxytryptamine receptor agonists (triptans), selective serotonin reuptake inhibitors (SSRIs) or selective serotonin/norepinephirne reuptake inhibitors (SNRIs) may result in life-threatening serotonin syndrome. Rockville, MD; 2006 Jul 19. From the FDA website: ( and ).

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