NORTRIPTYLINE HYDROCHLORIDE capsule

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Physicians Total Care, inc.

INN (Nama Internasional):

NORTRIPTYLINE HYDROCHLORIDE

Komposisi:

NORTRIPTYLINE HYDROCHLORIDE 10 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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.

Ringkasan produk:

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 54868-2835-2);bottles of 60 (NDC 54868-2835-1);bottles of 90 (NDC 54868-2835-4); and bottles of 100 (NDC 54868-2835-3). 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 25 (NDC 54868-2480-4); bottles of 30 (NDC 54868-2480-2); bottles of 60 (NDC 54868-2480-1); and bottles of 100 (NDC 54868-2480-0). 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 54868-2481-2); bottles of 60 (NDC 54868-2481-3); and bottles of 100 (NDC 54868-2481-1). 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 54868-2482-2); and bottles of 100 (NDC 54868-2482-0). 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 Repackaging and Relabeling by: Physicians Total Care, Inc. Tulsa, OK    74146

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

NORTRIPTYLINE HYDROCHLORIDE - NORTRIPTYLINE HYDROCHLORIDE CAPSULE
PHYSICIANS TOTAL CARE, INC.
----------
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.
The 10 mg, 25 mg a