Primox (Generic Nortriptyline Hydrochloride Tablets)

Generic Nortriptyline
Hydrochloride Tablets
© Clearsky Pharmacy
Primox (Generic Nortriptyline Hydrochloride
Tablets) is used to treat the symptoms of
depression. Generic Nortriptyline tablets are also
used for the treatment of nicotine dependence
as an aid to smoking cessation.

Primox Tablets
Primox Tablets are manufactured by
Sun Pharmaceutical Industries Ltd.
(Website: www.sunpharma.com)

Nortriptyline Hydrochloride Tablets – Brand
Names
Nortriptyline Hydrochloride tablets are
available as Primox, Sensoval,
Aventyl, Pamelor, Norpress, Allegron,
Noritren, Sensival, and Nortrilen.

Active Ingredient
The active ingredient contained in Primox
tablets is Nortriptyline Hydrochloride. Each
Primox tablet, for oral administration, contains
Nortriptyline Hydrochloride, USP equivalent to
25 mg of Nortriptyline.

Chemical Structure
The structure of Nortriptyline Hydrochloride
is given below:

Uses of Generic Nortriptyline Tablets
Generic Nortriptyline Hydrochloride Tablets
(Primox) belong to a group of medicines
called tricyclic antidepressants (TCAs) and
are used to treat depression. Symptoms of
depression can include feeling low in spirit,
loss of interest in activities, being unable to
enjoy life, poor appetite or overeating,
disturbed sleep, often waking up early, loss
of sex drive, lack of energy and feeling guilty
over nothing.
Generic Nortriptyline is also used as an aid
to smoking cessation and may help you stop
smoking.

Storage Instructions
Generic Nortriptyline tablets (Primox)
have to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F
to 77°F).
Keep this as well as all other medicines
away from children and pets.

Warnings
Patients with major depressive disorder
(MDD), both adult as well as pediatric,
can experience worsening of their
depression and/or the emergence of
suicidal ideation and behavior
(suicidality) or unusual changes in
behavior, irrespective of whether they
are taking antidepressant medications
like Primox, and this risk may persist
until significant remission occurs.

Primox Dosage
➢ Primox (Generic Nortriptyline Tablets)
should be swallowed whole, and taken
with a full glass of water. The
recommended adult dose for the relief of
symptoms of depression is 25 mg 3 or 4
times daily. Dosage should start at a low
level and be increased as required.
➢Generic Nortriptyline doses above 100
mg per day are not recommended.
The dosage of Primox tablets (Generic
Nortriptyline Hydrochloride) is given below:

Primox Dosage
➢ Start dosing prior to quit date at 25 mg/day and then
increase to 75 to 100 mg when feasible over 10 days
to 5 weeks. The recommended starting time is 10 to 28
days prior to the quit date and gradually increase to
achieve a maintenance dose of 75 to100 mg/day when
possible for a total of up to 12 weeks.
➢Although 12 weeks is the normal treatment duration,
the doctor should have the discretion to use the
medication for up to 6 months as a recent study shows
some decrease in relapse to smoking with extended
medication treatment.
The dosage of Primox (Generic Nortriptyline
Hydrochloride Tablets) for smoking cessation is
given below:

Primox Tablets
Contraindications
Primox is contraindicated in patients with a
hypersensitivity to Nortriptyline Hydrochloride or
any other component of this medication.
Generic Nortriptyline is contraindicated for the
treatment of depression in patients 12 years of
age and below.
Generic Nortriptyline is contraindicated for the
treatment of nocturnal enuresis.
The concurrent use of Generic Nortriptyline
Hydrochloride or other tricyclic antidepressants
with a monoamine oxidase inhibitor (MAOI) is
contraindicated.

Primox Tablets
Contraindications
Cross-sensitivity between Nortriptyline (Primox)
Hydrochloride and other dibenzazepines is a
possibility.
Primox (Generic Nortriptyline Tablets) is
contraindicated during the acute recovery period
after myocardial infarction.

Generic Nortriptyline Side Effects
➢The most common Generic Nortriptyline side effects include dry
mouth, sedation, constipation, and increased appetite, mild blurred
vision, tinnitus, often euphoria and mania. An occasional side effect
is a rapid or irregular heartbeat. Alcohol can increase some of its
side effects.
➢ Cardiovascular: Hypotension, hypertension, tachycardia,
palpitation, myocardial infarction, arrhythmias, heart block, stroke.
➢Psychiatric: Confusional states (especially in the elderly) with
hallucinations, disorientation, delusions; anxiety, restlessness,
agitation; insomnia, panic, nightmares; hypomania; exacerbation of
psychosis.
➢Neurologic: Numbness, tingling, paresthesias of extremities;
incoordination, ataxia, tremors; peripheral neuropathy;
extrapyramidal symptoms; seizures, alteration in EEG patterns;
tinnitus.
➢Anticholinergic: Dry mouth and, rarely, associated sublingual
adenitis; blurred vision, disturbance of accommodation, mydriasis;
constipation, paralytic ileus; urinary retention, delayed micturition,
dilation of the urinary tract.

Generic Nortriptyline Side Effects
➢Allergic: Skin rash, petechiae, urticaria, itching, photosensitization
(avoid excessive exposure to sunlight); edema (general or of face
and tongue), drug fever, cross-sensitivity with other tricyclic drugs.
➢Hematologic: Bone marrow depression, including agranulocytosis;
eosinophilia; purpura; thrombocytopenia.
➢Gastrointestinal: Nausea and vomiting, anorexia, epigastric
distress, diarrhea, peculiar taste, stomatitis, abdominal cramps,
blacktongue.
➢Endocrine: Gynecomastia in the male, breast enlargement and
galactorrhea in the female;increased or decreased libido,
impotence; testicular swelling; elevation or depression of blood
sugar levels; syndrome of inappropriate ADH (antidiuretic hormone)
secretion.
➢Other: Jaundice (simulating obstructive), altered liver function;
weight gain or loss; perspiration; flushing; urinary frequency,
nocturia; drowsiness, dizziness, weakness, fatigue; headache;
parotid swelling; alopecia.
➢Withdrawal Symptoms: Abrupt cessation of treatment after
prolonged therapy may produce nausea, headache, and malaise.

Generic Nortriptyline Overdose
Deaths may occur from overdosage with
Primox (Generic Nortriptyline Tablets).
Multiple drug ingestion (including alcohol)
is common in deliberate tricyclic
antidepressant overdose.
Signs and symptoms of toxicity develop
rapidly after tricyclic antidepressant
overdose; therefore, hospital monitoring is
required as soon as possible.

Symptoms of overdose include: cardiac
dysrhythmias, severe hypotension, convulsions,
and CNS depression, including coma. Changes in
the electrocardiogram, particularly in QRS axis or
width, are clinically significant indicators of
tricyclic antidepressant toxicity.
Other signs of Generic Nortriptyline overdose
may include confusion, disturbed concentration,
transient visual hallucinations, dilated pupils,
agitation, hyperactive reflexes, stupor,
drowsiness, muscle rigidity, vomiting,
hypothermia, hyperpyrexia, or many of the
symptoms listed under side effects.

Obtain an ECG and immediately start cardiac
monitoring. Protect the patient’s airway, establish
an intravenous line and initiate gastric
decontamination.
A bare minimum of six hours of observation with
cardiac monitoring and observation for signs of
CNS or respiratory depression, hypotension,
cardiac dysrhythmias and/or conduction blocks,
and seizures is necessary.
In case signs of toxicity occur at any time during
this period, extended monitoring is required.

Nortriptyline During Pregnancy
Primox (Generic Nortriptyline
Hydrochloride Tablets) has been
classified by the AU TGA as
Pregnancy Category C.
US FDA pregnancy category: Not
Assigned
There are no controlled studies in
pregnant women treated with
Nortriptyline.
Animal studies have shown
reproductive toxicity.

Generic Nortriptyline Tablets
For more details on
Primox Tablets click here
Primox (Generic Nortriptyline
Hydrochloride Tablets) by Sun
Pharmaceutical Industries Ltd., India.

Primox (Generic Nortriptyline Hydrochloride Tablets)

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