NORTRIPTYLINE HYDROCHLORIDE capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

NORTRIPTYLINE HYDROCHLORIDE (UNII: 00FN6IH15D) (NORTRIPTYLINE - UNII:BL03SY4LXB)

Disponibil de la:

Rebel Distributors Corp

INN (nume internaţional):

NORTRIPTYLINE HYDROCHLORIDE

Compoziție:

NORTRIPTYLINE HYDROCHLORIDE 10 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Nortriptyline hydrochloride is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states. The use of nortriptyline hydrochloride or other tricyclic antidepressants concurrently with a monoamine oxidase (MAO) inhibitor is contraindicated. Hyperpyretic crises, severe convulsions, and fatalities have occurred when similar tricyclic antidepressants were used in such combinations. It is advisable to have discontinued the MAO inhibitor for at least two weeks before treatment with nortriptyline hydrochloride is started. Patients hypersensitive to nortriptyline hydrochloride should not be given the drug. Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility. Nortriptyline hydrochloride is contraindicated during the acute recovery period after myocardial infarction.

Rezumat produs:

Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg nortriptyline) are #3, opaque deep green and opaque white capsules imprinted NORTRIPTYLINE and DAN 10 mg supplied in bottles of 30 (NDC 21695-093-30);bottles of 60 (NDC 21695-093-60); and bottles of 100 (NDC 21695-093-00). Nortriptyline Hydrochloride Capsules USP (equivalent to 25 mg nortriptyline) are #1, opaque deep green and opaque white capsules imprinted NORTRIPTYLINE and DAN 25 mg supplied in bottles of 30 (NDC 21695-094-30); bottles of 60 (NDC 21695-094-60). Nortriptyline Hydrochloride Capsules USP (equivalent to 50 mg nortriptyline) are #1, opaque white capsules imprinted NORTRIPTYLINE and DAN 50 mg supplied in bottles of 30 (NDC 21695-599-30); and bottles of 90 (NDC 21695-599-90). Nortriptyline Hydrochloride Capsules USP (equivalent to 75 mg nortriptyline) are #1, opaque deep green capsules imprinted NORTRIPTYLINE and DAN 75 mg supplied in bottles of 30 (NDC 21695-600-30). Dispense in a tight container, as defined in the USP, with a child-resistant closure. Store at 20°–25°C (68°–77°F). [See USP controlled room temperature.] Watson Laboratories, Inc. Corona, CA 92880 USA Revised: August 2007 0807B Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

NORTRIPTYLINE HYDROCHLORIDE- NORTRIPTYLINE HYDROCHLORIDE CAPSULE
REBEL DISTRIBUTORS CORP
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NORTRIPTYLINE
Suicidality and Antidepressant Drugs
ANTIDEPRESSANTS INCREASED THE RISK COMPARED TO PLACEBO OF SUICIDAL
THINKING AND BEHAVIOR
(SUICIDALITY) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT TERM
STUDIES OF MAJOR
DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. ANYONE
CONSIDERING THE USE OF
NORTRIPTYLINE HYDROCHLORIDE OR ANY OTHER ANTIDEPRESSANT IN A CHILD,
ADOLESCENT OR YOUNG ADULT
MUST BALANCE THIS RISK WITH THE CLINICAL NEED. SHORT TERM STUDIES DID
NOT SHOW AN INCREASE IN
THE RISK OF SUICIDALITY WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN
ADULTS AGED 65 AN OLDER.
DEPRESSION AND CERTAIN OTHER PSYCHIATRIC DISORDERS ARE THEMSELVES
ASSOCIATED WITH
INCREASES IN THE RISK OF SUICIDE. PATIENTS OF ALL AGES WHO ARE STARTED
ON THERAPY SHOULD BE
MONITORED APPROPRIATELY AND OBSERVED CLOSELY FOR CLINICAL WORSENING,
SUICIDALITY, OR UNUSUAL
CHANGES IN BEHAVIOR. FAMILIES AND CAREGIVERS SHOULD BE ADVISED OF THE
NEED FOR CLOSE
OBSERVATION AND COMMUNICATION WITH THE PRESCRIBER. NORTRIPTYLINE
HYDROCHLORIDE IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS: CLINICAL
WORSENING AND SUICIDE RISK
, PRECAUTIONS: INFORMATION FOR PATIENTS , AND PRECAUTIONS: PEDIATRIC
USE )
DESCRIPTION
Nortriptyline hydrochloride is 1-Propanamine, 3-(10,11-dihydro-5
_H_
-dibenzo[
_a,d_
]cyclohepten-5-ylidene)-
_N_
-methyl-, hydrochloride. The structural formula is represented below:
C
H N•HCl
M.W. 299.84
Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg, 25 mg,
50 mg and 75 mg
Nortriptyline), for oral administration, contain the following
inactive ingredients: colloidal silicon
dioxide, magnesium stearate, pregelatinized starch and sodium lauryl
sulfate. The 10 mg, 25 mg, 50 mg
and 75 mg capsule shells contain: gelatin, methylparaben,
propylparaben, sodium lauryl sulfate and
titanium dioxide. They may also contain: benzyl alcohol, butylparaben,
edetate calcium disodium, silicon
dioxide or sodium propionate.
1