Brand
name: TAVEGYL
(Anti-Hist, Clemastine, Tavist, Tavist-1)
Generic Name: TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1) fumarate
TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1) Description
TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1) belongs to the benzhydryl
ether group of antihistaminic compounds. The chemical name is (+) -
(2R) - 2 - [2 - [[(R) - p - Chloro - a - methyl - a - phenylbenzyl]
- oxy]ethyl] - 1 - methylpyrrolidine fumarate (1:1). Each tablet for
oral administration contains 1.34 or 2.68 mg of TAVEGYL (Anti-Hist,
Clemastine, Tavist, Tavist-1) fumarate.
Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Lactose,
Povidone, Pregelatinized Starch and Stearic Acid.
TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1) - Clinical Pharmacology
TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1) fumarate is an antihistamine
with anticholinergic (drying) and sedative side effects. Antihistamines
appear to compete with histamine for cell receptor sites on effector
cells. The inherently long duration of antihistaminic effects of TAVEGYL
(Anti-Hist, Clemastine, Tavist, Tavist-1) fumarate has been demonstrated
in wheal and flare studies. In normal human subjects who received histamine
injections over a 24-hour period, the antihistaminic activity of TAVEGYL
(Anti-Hist, Clemastine, Tavist, Tavist-1) reached a peak at 5-7 hours,
persisted for 10-12 hours and, in some cases, for as long as 24 hours.
Pharmacokinetic studies in man utilizing 3H and 14C labeled compound
demonstrates that: TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1)
is rapidly and nearly completely absorbed from the gastrointestinal
tract, peak plasma concentrations are attained in 2-4 hours, and urinary
excretion is the major mode of elimination.
Indications and Usage for TAVEGYL (Anti-Hist, Clemastine, Tavist,
Tavist-1)
TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1) Fumarate Tablets
1.34 mg are indicated for the relief of symptoms associated with allergic
rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation.
TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1) Fumarate Tablets
2.68 mg are indicated for the relief of symptoms associated with allergic
rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. TAVEGYL
(Anti-Hist, Clemastine, Tavist, Tavist-1) Fumarate Tablets 2.68 mg
are also indicated for the relief of mild, uncomplicated allergic skin
manifestations of urticaria and angioedema.
It should be noted that TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1)
fumarate is indicated for the dermatologic indications at the 2.68
mg dosage level only.
Contraindications Usage in Nursing Mothers
Because of the higher risk of antihistamines for infants generally
and for newborns and prematures in particular, antihistamine therapy
is contraindicated in nursing mothers.
Usage in Lower Respiratory Disease
Antihistamines should not be used to treat lower respiratory tract
symptoms including asthma.
Antihistamines are also contraindicated in the following conditions:
Hypersensitivity to TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1)
fumarate or other antihistamines of similar chemical structure. Monoamine
oxidase inhibitor therapy (see Drug Interactions section).
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 TAVEGYL (Anti-Hist, Clemastine,
Tavist, Tavist-1) 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
TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1) 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.
Precautions :AVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1) fumarate
should be used with caution in patients with: history of bronchial
asthma,
increased intraocular pressure, hyperthyroidism, cardiovascular disease,
and hypertension.MAO inhibitors prolong and intensify the anticholinergic
(drying) effects of antihistamines.
Adverse Reactions
Transient drowsiness, the most common adverse reaction associated
with TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1) 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 TAVEGYL (Anti-Hist,
Clemastine, Tavist, Tavist-1). 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.
3. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.
4. 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.
5. GI System:Epigastric distress, anorexia, nausea, vomiting, diarrhea,
constipation.
6. GU System: Urinary frequency, difficult urination, urinary retention,
early menses.
7. Respiratory System: Thickening of bronchial secretions, tightness
of chest and wheezing, nasal stuffiness.
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. TAVEGYL (Anti-Hist,
Clemastine, Tavist, Tavist-1)
Dosage and Administration
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE
OF THE PATIENT.
TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1) Fumarate Tablets
1.34 mg
The recommended starting dose is one tablet twice daily. Dosage may
be increased as required, but not to exceed six tablets daily.
TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1) Fumarate Tablets
2.68 mg
The maximum recommended dosage is one tablet three times daily. Many
patients respond favorably to a single dose which may be repeated as
required, but not to exceed three tablets daily.
How is TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1)
Supplied
TAVEGYL (Anti-Hist, Clemastine, Tavist, Tavist-1) 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).
