Primox Tablets (Generic Nortriptyline Hydrochloride Tablets)

Primox Tablets (Generic Nortriptyline Hydrochloride Tablets)
© The Swiss Pharmacy

Primox tablets (Generic Nortriptyline Hydrochloride tablets)
are used for the relief of symptoms of depression.
Endogenous depressions are more likely to be alleviated
than are other depressive states. It may help improve mood
and feelings of well-being, relieve anxiety and tension, and
increase your energy level. This medication belongs to a
class of medications called tricyclic antidepressants.
It is also a useful treatment for chronic neuropathic pain and
for the treatment of nicotine dependence as an aid to
smoking cessation.

Primox tablets are manufactured by
Sun Pharmaceutical Industries Limited,
India in the strength of 25 mg.

Chemical Structure

The active ingredient contained in Primox tablets is
Nortriptyline Hydrochloride.
Each film-coated Primox tablet contains Nortriptyline
Hydrochloride equivalent to 25 mg of Nortriptyline.

Uses of Primox 25 mg Tablets:
Nortriptyline is used to treat depression. It is thought to work by
increasing the activity of serotonin in the brain. Nortriptyline is a
tricyclic antidepressant.
It can also be used off-label for conditions such as chronic pain,
diabetic neuropathy, myofascial pain, orofacial pain, and
postherpetic neuralgia. Nortriptyline has also shown to be useful
in patients trying to quit smoking. Nortriptyline is not FDA
approved for use in children.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9720_Primox-Tablets.html

Recommended Adult Dosage
The adult dose of Primox tablets (Generic Nortriptyline
Hydrochloride tablets) for the relief of symptoms of depression
is 25 mg three or four times daily.
Dosage must begin at a low level and be increased as required.
As an alternate regimen, the total daily dosage may be given
once a day. When doses above 100 mg daily are administered,
plasma levels of Nortriptyline should be monitored and
maintained in the optimum range of 50 to 150 ng/mL.
Doses above 150 mg/day are not recommended.

Recommended Adult Dosage
The adult dose of Primox (Nortriptyline Hydrochloride) as an aid in
smoking cessation is administered orally. Start dosing prior to quit
date at 25 mg/day and then increase to 75 mg 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 to 100 mg/day when
possible for a total of up to 12 weeks.
The physician should maintain therapeutic monitoring for
vulnerable subjects, inadequate response and compliance
concerns. In case discontinuation is required Nortriptyline tablets
should be tapered as withdrawal symptoms can occur with
abrupt cessation.

Contraindications
➔
Primox is contraindicated in patients with a known hypersensitivity
to Nortriptyline Hydrochloride, Tricyclic Antidepressants or any
component of the tablet.
➔
The use of MAOIs intended to treat psychiatric disorders with
Nortriptyline Hydrochloride or within 14 days of stopping treatment
with nortriptyline hydrochloride is contraindicated because of an
increased risk of serotonin syndrome. The use of Nortriptyline
Hydrochloride within 14 days of stopping an MAOI intended to treat
psychiatric disorders is also contraindicated.

Contraindications
➔
Cross-sensitivity between Nortriptyline Hydrochloride (Primox
tablets) and other dibenzazepines is a possibility.
➔
Nortriptyline Hydrochloride is contraindicated during the acute
recovery period after myocardial infarction.
➔
Nortriptyline is contraindicated for the treatment of
depression in patients 12 years of age and under.

Storage Instructions
Primox Tablets (Generic Nortriptyline Hydrochloride
Tablets) have to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F to 77°F) with
excursions permitted between 15° to 30°C (59° to
86°F).
Keep this as well as all other medicines away from
children and pets.

Warnings
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 tablets or any other
antidepressant in a child, adolescent, or young adult must balance this
risk with the clinical need.
Patients with major depressive disorder (MDD), both adult and
pediatric, may experience worsening of their depression and/or the
emergence of suicidal ideation and behavior (suicidality) or unusual
changes in behavior, whether or not they are taking
antidepressant medications, and this risk may persist until significant
remission occurs.

Warnings
A major depressive episode may be the initial presentation of bipolar disorder.
It is generally believed that treating such an episode with any
antidepressant alone may increase the likelihood of a mixed/manic episode in
patients at risk for bipolar disorder. Before starting treatment with an
antidepressant, patients should be adequately screened to determine if they
are at risk for bipolar disorder. It should be noted that Nortriptyline tablets are not
approved for use in treating bipolar depression.
Patients and their caregivers should be alerted to the need to monitor for the
emergence of anxiety, agitation, panic attacks, insomnia, irritability,
hostility, impulsivity, akathisia, hypomania, mania, worsening of depression,
and suicidal ideation, especially early during antidepressant treatment. Such
symptoms should be reported to the patient’s doctor, especially if they are
severe, abrupt in onset, or were not part of the patient’s presenting
symptoms.

Warnings
In patients developing throat pain, fever and flu symptoms during
the first 10 weeks of treatment, it is recommended that a full blood
count is conducted to exclude agranulocytosis. Hyperpyrexia has
been reported during treatment with tricyclic antidepressants together
with anticholinergic or with neuroleptics, especially during hot weather.
Nortriptyline (Primox tablets) should be used with caution in
patients with cardiovascular disease, including heart failure,
conduction disorders (e.g. AV block grades I to III), or
arrhythmias. Cardiovascular and ECG monitoring should be
undertaken in such patients. An ECG should be performed prior to
starting treatment, at steady state, after an increase in dose or
after starting any potentially interacting medicine.

Warnings
If the medicine is given to overactive or agitated patients,
increased anxiety and agitation may occur. Troublesome patient
hostility may be aroused by the use of Nortriptyline
Hydrochloride.
Discontinue Primox tablets for several days, if possible, prior to
elective surgery. Both elevation and lowering of blood sugar levels
have been reported.
A case of significant hypoglycaemia has been reported after the
addition of Nortriptyline (125 mg/day) in a type II diabetic patient
maintained on Chlorpropamide (250 mg/day). Adjustment of anti-
diabetic therapy may, therefore, be necessary.

Possible Side Effects
The possible side effects of Primox (Generic Nortriptyline
Hydrochloride Tablets) are:
Cardiovascular – Hypotension, hypertension, tachycardia,
palpitation, myocardial infarction, arrhythmias, heart block, stroke.
Psychiatric – Confusional states 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.
Allergic – Skin rash, petechiae, urticaria, itching, photosensitization;
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, black tongue.

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
Though these are not indicative of Primox addiction, abrupt
cessation of treatment after prolonged therapy may produce
nausea, headache, Lack of appetite, Lower abdominal cramping and
pain, Diarrhea, Weight loss, Fever, Lower Back pain and malaise.
Taper dosage off slowly under medical supervision.

Primox Tablets Overdosage
Symptoms of Nortriptyline Hydrochloride (Primox tablets) overdose
include: cardiac dysrhythmias, severe hypotension, shock,
congestive heart failure, pulmonary edema, 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 overdose may include: confusion, restlessness,
disturbed concentration, transient visual hallucinations, dilated
pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle
rigidity, vomiting, hypothermia, hyperpyrexia, or any of the acute
symptoms listed under side effects.
There have been reports of patients recovering from Nortriptyline
overdoses of up to 525 mg.

Overdosage
In case of Nortriptyline Hydrochloride (Primox tablets) overdose, Obtain an
ECG and immediately start cardiac monitoring. Protect the patient’s
airway, establish an intravenous line and initiate gastric decontamination.
A 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. If signs
of toxicity occur at any time during this period, extended monitoring is
required.
All patients suspected of tricyclic antidepressant overdose should receive
gastrointestinal decontamination. This should include large volume gastric
lavage followed by activated charcoal. If consciousness is impaired, the
airway should be secured prior to lavage.
EMESIS IS CONTRAINDICATED.

Primox Tablets During Pregnancy
Nortriptyline Hydrochloride (Primox tablets) has been classified
by the US FDA as Pregnancy Category C.
Nortriptyline Hydrochloride (Primox tablets) should only be used
in pregnancy if considered necessary, taking into account the
risks of untreated depression, and under the close supervision of
a physician. Epidemiological studies have suggested an
increased risk of congenital abnormalities associated with
use of tricyclic antidepressants in pregnancy.

Primox Tablets During Pregnancy
There is evidence of interference with central monoamine
neurotransmission in rats. Neonates should be observed if maternal
use of Nortriptyline (Primox tablets) has continued into the later
stages of pregnancy, particularly into the third trimester.
Neonates exposed to tricyclic antidepressants, late in the third
trimester have shown drug withdrawal symptoms such as
dyspnoea, lethargy, colic irritability, hypotension or hypertension
and tremor or spasms.
Epidemiological data suggests that the use of tricyclic antidepressants
in pregnancy may be associated with an increase in pre-term delivery.

Primox Tablets (Generic Nortriptyline Hydrochloride
Tablets) are manufactured by Sun Pharmaceutical
Industries Limited, India.

Primox Tablets (Generic Nortriptyline Hydrochloride Tablets)

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