Prenity Total

Prenity Total Uses, Dosage, Side Effects, Food Interaction and all others data.

Mecobalamin is the neurologically active form of vitamin B12 and occurs as a water-soluble vitamin in the body. It is a cofactor in the enzyme methionine synthase, which functions to transfer methyl groups for the regeneration of methionine from homocysteine. In anaemia, it increases erythrocyte production by promoting nucleic acid synthesis in the bone marrow and by promoting maturation and division of erythrocytes.

Nortriptyline, a dibenzocycloheptadiene tricyclic antidepressant, is the primary active metabolite of amitriptyline. It increases synaptic concentration of serotonin and/or norepinephrine in the CNS by blocking the neuronal reuptake of norepinephrine and serotonin.

Nortriptyline exerts antidepressant effects likely by inhibiting the reuptake of serotonin and norepinephrine at neuronal cell membranes. It also exerts antimuscarinic effects through its actions on the acetylcholine receptor.

Prenity Total
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Prenity Total
Generic	Nortriptyline + Mecobalamin
Weight	10mg
Type	Tablet
Therapeutic Class
Manufacturer	Treatwell Pharma
Available Country	India
Last Updated:	September 19, 2023 at 7:00 am

Uses

Mecobalamin is used for-

Peripheral Neuropathies
Diabetic Neuropathy
Verteberal Syndrome
Nerve Compression Syndrome
Multiple sclerosis
Amyotrophic lateral sclerosis
Parkinson’s disease
Alzheimer’s disease
Diabetic retinopathy
Entrapment neuropathy
Drug induced neuropathy
Megaloblastic anemia due to Vitamin B12 deficiency

Nortriptyline is used for the treatment of depression and nocturnal enuresis.

Prenity Total is also used to associated treatment for these conditions: Vitamin B12 Deficiency, Nutritional supplementationIrritable Bowel Syndrome (IBS), Major Depressive Disorder (MDD), Myofascial Pain Syndrome, Orofacial Pain, Pain, Chronic, Post-Herpetic Neuralgia (PHN)

How Prenity Total works

Though prescribing information does not identify a specific mechanism of action for nortriptyline, is believed that nortriptyline either inhibits the reuptake of the neurotransmitter serotonin at the neuronal membrane or acts at the level of the beta-adrenergic receptors. It displays a more selective reuptake inhibition for noradrenaline, which may explain increased symptom improvement after nortriptyline therapy. Tricyclic antidepressants do not inhibit monoamine oxidase nor do they affect dopamine reuptake. As with other tricyclics, nortriptyline displays affinity for other receptors including mACh receptors, histamine receptors, 5-HT receptors, in addition to other receptors.

Dosage

Prenity Total dosage

Tablet: The usual adult dosage is one 500 mcg tablet three times daily. The dosage should be adjusted according to the age of patient and the severity of symptoms.

Injection:

Peripheral neuropathies: The usual adult dosage is one ampoule equivalent to 500 mcg of Mecobalamin, administered intramuscularly or intravenously three times a week.The dosage should be adjusted according to the age of patient and the severity of symptoms.
Megaloblastic anemia: The usual adult dosage is one ampoule equivalent to 500 mcg of Mecobalamin, administered intramuscularly or intravenously three times a week. After about two months of administration, dosage should be changed to one ampoule equivalent to 500 mcg of Mecobalamin every one to three months as maintenance therapy

Depression:

Adult: Low dose initially increased as necessary to 75-100 mg daily in divided doses or as a single dose (max. 150 mg daily)
Adolescent & Elderly: 30-50 mg daily in divided doses; Child not recommended for depression

Nocturnal enuresis:

Child 7 years: 10 mg
8-11 years: 10-20 mg
Over 11 years: 25-35 mg, 30 minutes before bedtime; max period of treatment (including gradual withdrawal) 3 months- full physical examination and ECG before further course.

Side Effects

Generally Mecobalamin is well tolerated. However, a few side effects like GI discomfort (including anorexia, nausea or diarrhea) & rash may be seen after administration of Mecobalamin.

The most common 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 may exacerbate some of its side effects and should be avoided.

Toxicity

The oral LD50 of nortriptyline in the rat is 405 mg/kg.Symptoms of overdose with nortriptyline include cardiac arrhythmias, severe hypotension, shock, congestive heart failure, pulmonary edema, convulsions, coma, and CNS depression. Changes in the electrocardiogram, particularly in QRS segment, may be indicative of tricyclic antidepressant toxicity.

Precaution

The medicine should not be used for months if there is no response at all after its use for a certain period of time.

Not intended for treatment of bipolar depression. Avoid abrupt withdrawal. Patient at risk of seizures, with DM, narrow angle glaucoma, urinary retention, prostatic hyperplasia, chronic constipation, history of CV disease. Renal and hepatic impairment. Elderly, childn. Pregnancy and lactation.

Interaction

Decreased GI tract absorption with neomycin, aminosalicylic acid, H2-blockers and colchicine. Reduced serum concentrations with oral contraceptives. Reduced effects in anaemia with parenteral chloramphenicol.

Nortriptyline should not be given with adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, phenylpropanolamine, drugs that are metabolized by CYP4502D6, MAOIs, guanethidine, debrisoquine, bethanidine, clonidine and reserpine etc. Barbiturates may increase the rate of metabolism of nortriptyline.

Volume of Distribution

The apparent volume of distribution (Vd)β, estimated after intravenous administration is 1633 ± 268 L within the range of 1460 to 2030 (21 ± 4 L/kg). Nortriptyline crosses the placenta and is found in the breast milk. It distributes to the heart, lungs, brain, and the liver.

Elimination Route

Nortriptyline is readily absorbed in the gastrointestinal tract with extensive variation in plasma levels, depending on the patient. This drug undergoes first-pass metabolism and its plasma concentrations are attained within 7 to 8.5 hours after oral administration. The bioavailability of nortriptyline varies considerably and ranges from 45 to 85%.

Half Life

The average plasma half-life of nortriptyline in healthy volunteers is about 26 hours, but is said to range from 16 to 38 hours. One study mentions a mean half-life of about 39 hours.

Clearance

The average plasma clearance of nortriptyline in a study of healthy volunteers was 54 L/h. The average systemic clearance of nortriptyline is 30.6 ± 6.9 L / h, within the range of 18.6 to 39.6 L/hour.

Elimination Route

Nortriptyline and its metabolites are mainly excreted in the urine, where only small amounts (2%) of the total drug is recovered as unchanged parent compound. Approximately one-third of a single orally administered dose is excreted in urine within 24 hours. Small amounts are excreted in feces via biliary elimination.

Pregnancy & Breastfeeding use

Not recommended during pregnancy & lactation.

The safety of nortriptyline for use in pregnancy has not been established. Nortriptyline should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Contraindication

Hypersensitivity to any component of this product.

Nortriptyline is contraindicated in patients with hypersensitivity to nortriptyline. Concomitant administration with MAOI is contraindicated. Do not use with or within 2 weeks of stopping an MAOI. Nortriptyline is contraindicated during the acute recovery period after myocardial infarction.

Special Warning

Use in children: Not recommended.

Acute Overdose

Symptoms: Severe hypotension, cardiac dysrhythmias, shock, CHF, pulmonary oedema, convulsions, and CNS depression, including coma; changes in ECG.

Management: Symptomatic and supportive treatment. Admin IV Na bicarbonate, benzodiazepines. Admin activated charcoal to reduce absorption. Emesis is contraindicated. Initiate cardiac monitoring and observe for signs of CNS or resp depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures.