Clemastine Fumarate

Northwind Pharmaceuticals
Northwind Pharmaceuticals

FULL PRESCRIBING INFORMATION: CONTENTS*

• How supplied
• Dosage and administration
• Overdosage
• Side Effects
• Drug Interactions
• Precautions
• Warnings

FULL PRESCRIBING INFORMATION

NDC: 51655-525-04

MFG: 0093-0308-01

Clemastine Fumarate 2.68mg

16 tablets

Rx Only

Lot#:

Exp. Date:

Each tablet contains: Clemastine Fumarate, USP....2.68mg

Dosage: See package insert

Store between 68-77 degrees F.

Protect from moisture. Store in a tight, light-resistant container (See USP).

Keep out of the reach of children.

Mfg by: Teva Pharmaceuticals USA. Sellersburg, PA 18960 Lot#

Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

How supplied

HOW SUPPLIED

Clemastine Fumarate Tablets 2.68 mg are white, round, scored tablets debossed with "93" and "308". Tablets are packaged in bottles of 100.

Store at controlled room temperature, between 20o and 25oC (68o and 77oF) (see USP).

Dispense in a tight, light-resistant container as defined in the USP/NF, with a child-resistant closure

Dosage and administration

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT

Overdosage

Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in children. Atropine-like signs and symptoms: dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur.

If vomiting has not occurred spontaneously the conscious patient should be induced to vomit. This is best done by having him drink a glass of water or milk after which he should be made to gag. Precautions against aspiration must be taken, especially in infants and children.

If vomiting is unsuccessful gastric lavage is indicated within 3 hours after ingestion and even later if large amounts of milk or cream were given beforehand. Isotonic and 1/2 isotonic saline is the lavage solution of choice.

Saline cathartics, such as milk of magnesia, by osmosis draw water into the bowel and therefore, are valuable for their action in rapid dilution of bowel content.

Stimulants should not be used.

Vasopressors may be used to treat hypotension

Side Effects

Transient drowsiness, the most common adverse reaction associated with clemastine fumarate, occurs relatively frequently and may require discontinuation of therapy in some instances

Antihistaminic Compounds

It should be noted that the following reactions have occurred with one or more antihistamines and, therefore, should be kept in mind when prescribing drugs belonging to this class, including clemastine. The most frequent adverse reactions are italicized.

1. General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of the mouth, nose, and throat.

2. Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles.Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

3. Nervous System:Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions.

4. GI System:Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.GU System: Urinary frequency, difficult urination, urinary retention, early menses.

5. Respiratory System: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.

Drug Interactions

MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines

Precautions

Clemastine fumarate should be used with caution in patients with: history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease, and hypertension.

Warnings

WARNINGS

Antihistamines should be used with considerable caution in patients with: narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction.

Usage in Children

Safety and efficacy of clemastine fumarate have not been established in children under the age of 12 years.

Usage in Pregnancy

Experience with this drug in pregnant women is inadequate to determine whether there exists a potential for harm to the developing fetus.

Usage with CNS Depressants

Clemastine has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.).

Usage in Activities Requiring Mental Alertness

Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.

Usage in the Elderly (approximately 60 years or older)

Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.