TOFRANIL- imipramine hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

imipramine hydrochloride (UNII: BKE5Q1J60U) (imipramine - UNII:OGG85SX4E4)

Available from:

Geigy Pharmaceuticals

INN (International Name):

imipramine hydrochloride

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

25 mg in 2 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Depression : For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. The concomitant use of monoamine oxidase inhibiting compounds is contraindicated. Hyperpyretic crises or severe convulsive seizures may occur in patients receiving such combinations. The potentiation of adverse effects can be serious, or even fatal. When it is desired to substitute Tofranil in patients receiving a monoamine oxidase inhibitor, as long an interval should elapse as the clinical situation will allow, with a minimum of 14 days. Initial dosage should be low and increases should be gradual and cautiously prescribed. The drug is contraindicated during the acute recovery period after a myocardial infarction. Patients with a known hypersensitivity to this compound should not be given the drug. The possibility of cross-sensitivity to other dibenzazepine compounds should be k

Product summary:

Ampul s 2 mL – For in t ramuscular administration only 25 mg imipramine hydrochloride, 2 mg ascorbic acid, 1 mg sodium bisulfite, 1 mg sodium sulfite, anhydrous Boxes of 10 ........................................................................................ NDC 0028-0065-23 Store between 59º-86ºF (15º-30ºC). Note: Upon storage, minute crystals may form in some ampuls. This has no influence on the therapeutic efficacy of the preparation, and the crystals redissolve when the affected ampuls are immersed in hot tap water for 1 minute.

Summary of Product characteristics

TOFRANIL- IMIPRAMINE HYDROCHLORIDE INJECTION, SOLUTION
GEIGY PHARMACEUTICALS
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TOFRANIL
TOFRANIL
IMIPRAMINE HYDROCHLORIDE USP
Ampuls
For intramuscular administration
PRESCRIBING INFORMATION
DESCRIPTION
Tofranil, imipramine hydrochloride USP, the original tricyclic
antidepressant, is available in ampuls for
intramuscular administration. Each 2 mL ampul contains imipramine
hydrochloride USP, 25 mg; ascorbic
acid, 2 mg; sodium bisulfite, 1 mg; sodium sulfite, anhydrous, 1 mg.
Tofranil is a member of the
dibenzazepine group of compounds. It is designated 5-[3-
(dimethylamino)propyl]-10,11-dihydro-5_H_-
dibenz[b,f]azepine monohydrochloride. Its structural formula is
Imipramine hydrochloride USP is a white to off-white, odorless, or
practically odorless crystalline
powder. It is freely soluble in water and in alcohol, soluble in
acetone, and insoluble in ether and in
benzene. Its molecular weight is 316.87.
CLINICAL PHARMACOLOGY
The mechanism of action of Tofranil is not definitely known. However,
it does not act primarily by
stimulation of the central nervous system. The clinical effect is
hypothesized as being due to
potentiation of adrenergic synapses by blocking uptake of
norepinephrine at nerve endings. The mode of
action of the drug in controlling childhood enuresis is thought to be
apart from its antidepressant effect.
INDICATIONS AND USAGE
_Depression_: For the relief of symptoms of depression. Endogenous
depression is more likely to be
alleviated than other depressive states. One to three weeks of
treatment may be needed before optimal
therapeutic effects are evident.
CONTRAINDICATIONS
The concomitant use of monoamine oxidase inhibiting compounds is
contraindicated. Hyperpyretic
crises or severe convulsive seizures may occur in patients receiving
such combinations. The
potentiation of adverse effects can be serious, or even fatal. When it
is desired to substitute Tofranil in
patients receiving a monoamine oxidase inhibitor, as long an interval
should elapse as the clinical
®
situation will allow, wit