Primox Tablets by Sun (Generic Nortriptyline Hydrochloride Tablets)

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Primox Tablets by Sun (Generic Nortriptyline Hydrochloride Tablets)

Primox (Generic Nortriptyline Hydrochloride Tablets)
is used for the relief of symptoms of depression. It
may also be used for the treatment of some cases of
nocturnal enuresis.
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 works
by affecting the balance of certain natural chemicals
in the brain.

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

Chemical Structure
The structure of Nortriptyline Hydrochloride is given below:

Primox Tablets are manufactured by Sun
Pharmaceutical Industries Limited, India in strengths of
25 mg.
(Website: www.sunpharma.com)
URL: https://www.clearskypharmacy.biz/generic-aventyl-primox-by-sun-pharma.html

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

Uses of Primox Tablets
Primox (Generic Nortriptyline Tablets) is used for the relief of
symptoms of depression. Endogenous depressions are more likely to
be alleviated than are other types of depressive states.
Generic Nortriptyline Hydrochloride is also used for the treatment of
nicotine dependence as an aid to smoking cessation. Controlled trials
have shown that Nortriptyline is an efficacious aid to smoking cessation
with a magnitude of effect similar to that for Bupropion and nicotine
replacement therapies. (https://pubmed.ncbi.nlm.nih.gov/16085520/)
Nortriptyline Hydrochloride is a tricyclic antidepressant that is also
occasionally used for treating neuropathic pain.

Primox Tablets Dosage
The dosage of Primox tablets (Generic Nortriptyline
Hydrochloride Tablets) is given below:
Usual Adult Dose For the Relief of Symptoms of Depression:
For the treatment of depression the usual adult dose is 25 mg
of Generic Nortriptyline 3 or 4 times daily. The dosage should
begin at a low level and be increased as required.
As an alternate dosage regimen, the total daily dosage may be
given once a day. Doses above 100 mg per day are not
recommended.

Primox Tablets Dosage
The dosage of Primox tablets (Generic Nortriptyline
Hydrochloride Tablets) is given below:
As an Aid in Smoking Cessation:
Generic Nortriptyline Hydrochloride is administered orally in
the form of tablets. The dosing has to be started prior to quit
date at 25 mg/day and then increased to 75 mg to 100 mg
when feasible over 10 days to 5 weeks. The recommended
starting time is 10 days to 28 days prior to the quit date and
gradually increase to achieve a maintenance dose of 75 mg to
100 mg/day when possible for a total of up to 12 weeks.

Contraindications
Primox is contraindicated in patients hypersensitive to Nortriptyline
Hydrochloride or to any other ingredient present in the medication.
Use of Primox (Generic Nortriptyline Hydrochloride Tablets) or
other tricyclic antidepressants concurrently with a monoamine
oxidase (MAO) inhibitor is contraindicated. The MAO inhibitor has to
be discontinued for at least two weeks before treatment with
Primox tablets (Nortriptyline HCl) is started.
Starting Nortriptyline Hydrochloride in a patient who is being
treated with MAOIs such as linezolid or intravenous methylene blue
is also contraindicated because of an increased risk of serotonin
syndrome.

Contraindications
Primox is contraindicated is contraindicated for the treatment
of nocturnal enuresis.
Primox (Generic Nortriptyline Tablets) is contraindicated
during the acute recovery period after myocardial infarction.

Storage Instructions
Primox (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 the medicine 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.

Effects On Ability To Drive And Use Machines
Nortriptyline Hydrochloride (Primox Tablets) has moderate influence
on the ability to drive and use machines.
Nortriptyline may impair the mental and/or physical abilities required
for the performance of hazardous tasks, such as operating machinery
or driving a car; therefore the patient should be warned accordingly.

Primox Tablets And Alcohol
You can drink alcohol while taking Nortriptyline but it can alter the effects of
Nortriptyline and cause increased side effects.
Excessive consumption of alcohol in combination with Nortriptyline therapy may have
a potentiating effect, which may lead to the danger of increased suicidal attempts or
overdosage,
especially in patients with histories of emotional disturbances or suicidal ideation. The
patient should be informed that the response to alcohol may be exaggerated
Additionally, alcohol can increase the sedative effects of Nortriptyline, which means it
may make you feel drowsy, impair your motor skills, impair your ability to drive (not
that you should be driving after drinking, anyhow) or operate heavy machinery, etc.
And if you’re taking or have recently taken non-steroidal anti-inflammatory drugs
(NSAIDs) are also at an increased risk of gastrointestinal bleeding when also taking
Nortriptyline and consuming alcohol.
It might be best to stop drinking alcohol until you see how the medicine makes you
feel.

Side Effects
The common side effects of Nortriptyline Hydrochloride
(Primox Tablets) are Stomach or bowel problems (e.g.
nausea, diarrhoea, constipation), Dry mouth or taste change,
Change in appetite, Shakiness or tremor, Trouble sleeping,
Dizziness or light-headedness (especially on standing
rapidly), Tingling or numbness of the hands or feet, Ringing
or other persistent noise in the ears, and Difficulty in passing
urine.

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.
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.

Side Effects
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.

Primox Tablets 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.

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. In case signs of toxicity occur at any time during
this period, extended monitoring is required.

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.
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.

Primox Tablets During Nursing
Notriptyline (Primox Tablets) passes into breast milk in very small
amounts so it's unlikely to cause any harm to your baby. If you are being
treated for depression it's important to continue taking Notriptyline to
keep you well. Breastfeeding will also benefit both you and your baby.
Because of the low levels of Notriptyline in breast milk, amounts
ingested by the infant are small and usually not been detected in the
serum of the infant, although the less active metabolites are often
detectable in low levels in infant serum.
Immediate side effects have not been reported and a limited amount of
follow-up has found no adverse effects on infant growth and
development. A safety scoring system finds Notriptyline use to be
possible with caution during breastfeeding.

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

Primox Tablets by Sun (Generic Nortriptyline Hydrochloride Tablets)

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