Novotil Uses

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What is Novotil?

Novotil is a medicine that increases the movements or contractions of the stomach and bowel. Novotil is also used to treat nausea and vomiting caused by other drugs used to treat Parkinson's Disease.

Novotil is to be given only by or under the immediate supervision of your doctor.

Novotil indications

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Dyspeptic symptom complex often associated with delayed gastric emptying, gastroesophageal reflux disease (GERD) or esophagitis: Epigastric sense of fullness, feeling of abdominal distention, upper abdominal pain, flatulence (gassiness), eructation (belching), and heartburn.

Short-term treatment of nausea and vomiting of various origins including functional, organic, infectious, diabetic origin, or induced by radiotherapy or medicine therapy. (It is not considered suitable for chronic nausea and vomiting, nor for the routine prophylaxis of postoperative vomiting.)

Treatment of nausea and vomiting induced by dopamine agonists ie, L-dopa and bromocriptine used in Parkinson's disease.

Novotil may also be given as needed, together with paracetamol for the symptomatic treatment of nausea and vomiting associated with migraine.

Uses of Novotil in details

Novotil is used to treat vomiting or nausea caused due to indigestion, diseases or drugs. It is also used to relieve fullness of stomach, belching and heavy bloating, gas and heartburn for a longer period up to 2 weeks.

Novotil description

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Novotil is a synthetic anticoagulant and an indanedione derivative. It prevents the formation of active procoagulation factors II, VII, IX, and X, as well as the anticoagulant proteins C and S, in the liver by inhibiting the vitamin K mediated gamma-carboxylation of precursor proteins.

Novotil dosage

It is recommended to take oral Novotil before meals. If taken after meals, absorption of the drug is somewhat delayed.

Adults and Adolescents >12 years and weighing ≥35 kg: Tablets: One to two 10-mg tablet 3-4 times/day, with a maximum daily dose of 8 tablets (80 mg).

Oral Suspension:

10-20 mL (of oral susp containing Novotil 1 mg/mL) 3-4 times/day, with a maximum daily dose of 80 mL.

Infants and Children: 0.25-0.5 mg/kg 3-4 times/day with a maximum daily dose of 2.4 mg/kg (but do not exceed 80 mg/day).

Tablets are unsuitable for use in children weighing <35 kg.

Oral Suspension:

0.25-0.5 mg/kg 3-4 times/day with a maximum dose of 2.4 mg/kg (not exceeding 80 mL).

Novotil interactions

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The concomitant administration of Novotil with phenothiazines, butyrophenones and rauwolfia alkaloids may induce the endocrine disturbances or extrapyramidal disorders. If necessary, monitored carefully and administered cautiously.

Should be administered cautiously in patients receiving digitalis preparations.

The concomitant administration of Novotil with anticholinergic agents may compromise the beneficial effects of Novotil because of depressing the promoting action of gastrointestinal motility.

Theologically, Novotil may have an effect on the absorption of oral preparations, especially slow-releasing or enteric-coated preparations because of increasing gastric motility. But in patients stabilized with digoxin or acetaminophen, the concomitant administration of Novotil had no effect on plasma concentration of these drugs.

It is not reported that Novotil enhances the effect of neuroleptics.

Novotil inhibits peripheral adverse reactions eg, dyspepsia, nausea, vomiting, induced by dopamine agonist (eg, bromocriptine, levodopa), but has no effect on central nervous system.

As the concomitant administration of Novotil with antacids or acid secretion inhibitors lowers biologic activity of Novotil, these drugs should not be used together.

The actions of Novotil on gastrointestinal function may be antagonised by antimuscarinics and opioid analgesics.

Novotil side effects

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What are the possible side effects of Novotil?

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Clinical Trial Data: The safety of Novotil was evaluated in 1221 patients with gastroparesis, dyspepsia, gastro-oesophageal reflux disorder (GERD) or other related conditions in 45 clinical trials included in the safety database. All patients were ≥15 years and received at least 1 dose of oral Novotil (Novotil base). Slightly fewer than one-half (553/1221) of patients were diabetic. The median total daily dose was 80 mg (range 10-160 mg), with 230 patients receiving a dose >80 mg. Median duration of exposure was 56 days (range 1-2248 days).

Adverse drug reactions (ADRs) reported by ≥1% of patients treated with oral Novotil in these 45 clinical trials (n=1221) are the following: Psychiatric Disorders: Depression (2.5%), anxiety (1.6%), decreased libido/loss of libido (1.5%).

Nervous System Disorders: Headache (5.6%), somnolence (2.5%), akathisia (1%).

Gastrointestinal Disorders: Diarrhoea (5.2%).

Skin and Subcutaneous Tissue Disorders: Rash (2.8%), pruritus (1.7%).

Reproductive System and Breast Disorders: Breast enlargement/gynaecomastia (5.3%), breast tenderness (4.4%), galactorrhoea (3.3%), amenorrhoea (2.9%), breast pain (2.3%), irregular menstruation (2%), lactation disorder (1.6%).

General Disorders and Administration Site Conditions: Asthenia (1.9%).

ADRs that occurred in <1% of Novotil-treated patients in the 45 clinical trials (n=1221) are the following: Immune System Disorders: Hypersensitivity (0.2%).

Skin and Subcutaneous Disorders: Urticaria (0.7%).

Reproductive System and Breast Disorders: Breast discharge (0.8%), breast swelling (0.5%).

Dry mouth has been reported with over-the-counter use of Novotil.

Post-Marketing: In addition to the adverse effects reported during clinical studies and previously mentioned, the following adverse drug reactions provided the frequencies according to the following convention: Very common (≥1/10), common (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10,000 and <1/1000); very rare (<1/10,000, including isolated reports).

The following ADRs are presented by frequency category based on spontaneous reporting rates: Immune System Disorders: Very Rare: Anaphylactic reactions (including anaphylactic shock).

Psychiatric Disorders: Very Rare: Agitation, nervousness.

Nervous System Disorders: Very Rare: Extrapyramidal disorder, convulsion.

Cardiac Disorders: Very Rare: Sudden cardiac death*, serious ventricular arrhythmias*.

Skin and Subcutaneous Tissue Disorders: Very Rare: Angioedema.

Renal and Urinary Disorders: Very Rare: Urinary retention.

Investigations: Very Rare: Abnormal liver function test; increased blood prolactin.

Note: *Based on epidemiology data (as follows).

As the hypophysis is outside the blood-brain barrier, Novotil may cause an increase in prolactin levels. In rare cases, this hyperprolactinaemia may lead to neuro-endocrinological side effects eg, galactorrhoea, gynaecomastia and amenorrhoea.

Extrapyramidal disorder occurs primarily in neonates and infants.

Other central nervous system-related effects of convulsion and agitation are also reported primarily in infants and children.

An increase in the risk of serious ventricular arrhythmias and sudden cardiac death has been reported in some epidemiology studies. Due to the limitations of these data, risk factors and the exact frequency of these adverse reactions could not be defined.

Novotil contraindications

Hypersensitivity to Novotil or any ingredient of Novotil.

If patients are taking oral ketoconazole, fluconazole, voriconazole, erythromycin, clarithromycin, telithromycin, amiodarone, selective serotonin reuptake inhibitors, HIV protease inhibitors, calcium antagonists which can increase plasma concentrations of Novotil, leading to a prolonged QTc interval. These medicines can increase plasma concentrations of Novotil leading to a prolonged QTc interval. Patients with long QT syndrome develop a very fast heart rhythm disturbance leading to a sudden loss of consciousness.

Gastrointestinal hemorrhage (bleeding), obstruction, perforation or conditions where gastrointestinal stimulation or movements may be dangerous.

Prolactin-releasing pituitary tumor (prolactinoma).

Active ingredient matches for Novotil:

Domperidone in Indonesia.

Tenoxicam in India.


Unit description / dosage (Manufacturer)Price, USD
NOVOTIL Capsule/ Tablet / 20mg / 10 units (Cadila Pharmaceuticals (Recon Healthcare))$ 0.65
20 mg x 50's$ 3.26
Novotil 20mg TAB / 50$ 3.26
Novotil 20 mg Tablet$ 0.07
NOVOTIL tab 20 mg x 10's (Zydus Cadila)$ 0.65

List of Novotil substitutes (brand and generic names):

Novom 10 mg Tablet (Talent Laboratories)$ 0.02
Tablet; Oral; Domperidone Maleate 10 mg
Nucid D 20+10 Tablet (Dr Alson Laboratories Pvt Ltd)$ 0.07
Nudom 10 mg Tablet (Mankind Pharmaceuticals Pvt. Ltd.)$ 0.02
NUDOM 10MG TABLET 1 strip / 10 tablets each (Mankind Pharmaceuticals Pvt. Ltd.)$ 0.15
Nudom 10mg Tablet (Mankind Pharmaceuticals Pvt. Ltd.)$ 0.02
Nudon 2 mg Tablet (Magnet Labs Pvt Ltd (Mankind Pharmaceuticals Pvt. Ltd))$ 0.04
Nudon 3 mg Tablet (Magnet Labs Pvt Ltd (Mankind Pharmaceuticals Pvt. Ltd))$ 0.03
Nudon 1 mg Tablet (Magnet Labs Pvt Ltd (Mankind Pharmaceuticals Pvt. Ltd))$ 0.01
Nuloc D 20+30 Capsule (Bergen (Alkem Laboratories Ltd))$ 0.06
NULOC D 30MG/20MG CAPSULE 1 strip / 10 capsules each (Bergen (Alkem Laboratories Ltd))$ 0.73
Nuloc D 30mg/20mg Capsule (Bergen (Alkem Laboratories Ltd))$ 0.07
Numcid D 20+10 Capsule (Manum Healthcare Pvt. Ltd.)$ 0.05
Obeba D 20+10 Capsule (Hamax Pharmaceuticals)$ 0.04
Ocid D 20+10 Capsule (Cadila Healthcare (Zydus Cadila Healthcare Ltd))$ 0.09
Ocid D 20+30 Capsule (Cadila Healthcare (Zydus Cadila Healthcare Ltd))$ 0.09
OCID D 10MG/20MG CAPSULE 1 strip / 10 capsules each (Cadila Healthcare (Zydus Cadila Healthcare Ltd))$ 1.38
OCID D CAPSULE 1 strip / 10 capsules each (Cadila Healthcare (Zydus Cadila Healthcare Ltd))$ 1.20
Ocidom MD 10 mg Tablet (Biocin Genetics & Pharma)$ 0.03
OD 20 20+10 Capsule (Brawn Laboratories Ltd.)$ 0.06
Odik 20+10 Capsule (Ascent Corporations (Pvt) Ltd)$ 0.06
Odipan DSR 40+30 Capsule (Radix (Solitaire Pharmacia Pvt Ltd))$ 0.08
Odom 20+10 Tablet (Siesta Pharmaceuticals)$ 0.05
ODOM 10MG/20MG CAPSULE 1 strip / 10 capsules each (Siesta Pharmaceuticals)$ 0.58
ODOM 30MG/20MG CAPSULE 1 strip / 10 capsules each (Siesta Pharmaceuticals)$ 0.60
Odom 10 mg/20 mg Capsule (Siesta Pharmaceuticals)$ 0.06
Odom 30 mg/20 mg Capsule (Siesta Pharmaceuticals)$ 0.06
Ogestrel D 20+10 Capsule (Scoshia Remedy Inc.)$ 0.05
Ohio D 20+10 Tablet (Brooks Pharmaceuticals)$ 0.06
Olla D 20+10 Tablet (Sienna Formulations Pvt Ltd.)$ 0.05
Olmax D 20+10 Tablet (Biomax Laboratories)$ 0.05
Oltacid 40+20 Tablet (Altar Healthcare (P) Ltd.)$ 0.07
Om D 20+10 Innova Capsule (Innova Formulations Pvt Ltd)$ 0.06
Om D 20+10 Pharma Drugs Capsule (Innova Formulations Pvt Ltd)$ 0.06
OM DM 20+10 Tablet (Devi Formulations Pvt Ltd.)$ 0.05
Oma D 20+10 Tablet (Geneka Biotec)$ 0.05
Oma D 20+30 Capsule (Geneka Biotec)$ 0.08
Omac DM 20+10 Capsule (Oscar Remedies Pvt. Ltd.)$ 0.05

References

  1. PubChem. "tenoxicam". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. PubChem. "domperidone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "domperidone". http://www.drugbank.ca/drugs/DB01184 (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Novotil are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Novotil. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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1 consumer reported age

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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