Lafaxid-10 tablets
Therapy Area
Gastrointestinal
1.0 Generic name
Lafutidine Tablets
(brand name- LAFAXID-10 tablet)
2.0 Qualitative and quantitative composition
Each film-coated tablet contains:
Lafutidine 10 mg.
Excipients q. s
Colour: Titanium Dioxide I P
3.0 Dosage form and strength
Film coated tablets
Lafutidine 10 mg
4.0 Clinical particulars
4.1 Therapeutic Indication
For the treatment of:
- gastric ulcers, duodenal ulcers and stromal ulcers.
- gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis and acute exacerbation of chronic gastritis.
4.2 Posology And Method of Administration
- Gastric ulcers, duodenal ulcers and stromal ulcers For Adults- 1 tablet two times daily, one after breakfast and one after evening meal or before sleeping. Dose must be adjusted according to patients age and symptoms.
- Gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis and acute exacerbation of chronic gastritis. For Adults-1 tablet once daily, after evening meal or before sleeping. Dose must be adjusted according to patients age and symptoms.
4.3 Contraindications
Patients with a history of drug hypersensitivity to any of the ingredients in the product.
4.4 Warning and Precautions
Lafutidine should be administered with care in patients with a history of drug hypersensitivity, impaired hepatic function, impaired renal function and patients on dialysis.
Use in the Elderly
Normally, because physiological function is deteriorated in the elderly, it is advisable to take such measures as a reduction in the dose and a prolongation of the administration interval under careful supervision.
4.5 Drug Interactions
Not known
4.6 Special populations
Pregnancy and Lactation
The safety of Lafutidine in pregnant women has not been established. Therefore, the administration of Lafutidine to pregnant women or women who may possibly be pregnant should be strictly limited to occasions where the therapeutic benefits outweigh the possible risks associated with the treatment. Animal studies (in rats) have shown that lafutidine is excreted in breast milk. Therefore, the mothers should be advised to discontinue breast feeding during treatment.
Pediatric use
This lafutidine drug can be used in children
4.7 Effects on ability to drive and use machines
The effects of the medicinal product on the ability to drive and use machines have not been studied.
4.8 Undesirable Effects
Constipation, diarrhea, drug rash, nausea or vomiting and dizziness are the adverse reactions observed during clinical trials. Other adverse effects of unknown frequency include abnormal changes in laboratory tests, hypersensitivity reactions (itching, redness of the skin, skin rash)
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via
email to: medico@zuventus.com
By reporting side effects, you can help provide more information on the safety of this medicine.
4.9: Overdose
No data on overdosage with Lafutidine tablet is available.
5.0 Pharmacological properties
5.1 Mechanism of Action /5.2 Pharmacodynamic Properties
Lafutidine inhibits acid secretion via histamine H2-receptor blockade. It also possesses a cytoprotective efficacy, which comprises mucin biosynthesis, stimulation of gastric blood flow and promotion of epithelial restitution of damaged mucosa, mediated through capsaicin-sensitive sensory neurons and endogenous calcitonin gene-related peptide (CGRP). It increases the endothelial production of prostacyclin, which inhibits neutrophil activation and reduces inflammation. It also affects gastrointestinal functions by regulating gastrointestinal motility closely relate to changes in the plasma levels of somatostatin, CGRP and secretin.
5.3 Pharmacokinetic properties
When 10mg of lafutidine is orally administered to normal adult males in fasting conditions, peak plasma concentration of 265.15±49.84 ng/ml is achieved at 0.95±0.24 hours. Lafutidine is metabolized primarily in the liver. In vitro studies showed that lafutidine is mainly metabolized by CYP3A4 and partially metabolized by CYP2D6. Hydroxylated and sulfonyl lafutidine are the major metabolites. Most of the drug is excreted in bile while approximately 20% of the given dosage is excreted in urine. The plasma half-life is 1.92 ± 0.94 hours. Among the elderly, there was no difference in pharmacokinetics parameters between those with normal renal function and those with deteriorating renal function. In dialytic patients when administered without hemodialysis, the Cmax, AUC and the T1/2 values were 336±40 ng/ml, 2278±306 ng･hr/mL and 6.71±0.30 hours respectively while those after hemodialysis were 226±36 ng/ml, 853±128 ng･hr/mL and 4.57±0.2 hours respectively.
6.0 Nonclinical properties
6.1 Animal Toxicology or Pharmacology
No known animal toxicology data
7.0 Description
Lafutidine is a second-generation histamine receptor antagonist (H2-RA) possessing an antisecretory effect as well as gastro-protective activity against several necrotizing agents independent of its antisecretory action.
Molecular Formula: C22H29N3O4S
Chemical name: 2-(Furfurylsulfinyl)-N-[4-[4-(piperidinomethyl)-2-pyridyl]oxy-(Z)-2-butenyl]acetamide Molecular weight: 431.56 Structural formula:
8.0 Pharmaceutical particulars
8.1 Incompatibilities
Not applicable
8.2 Shelf Life
Refer on the pack.
8.3 Packaging Information
3 composite blister strips of 3 x 10 tablets each.
8.4 Storage and Handling Instructions
Store in a cool dry place.
Keep out of reach of children.
9.0 Patient counseling information
- Take Lafutidine before going to bed if you are taking this medicine once a day. It is very effective in controlling stomach acid that is released when you are asleep.
- If you are also taking other medications to treat acidity (e.g., antacid), take them 2 hours before or after taking Lafutidine.
- Avoid taking soft drinks, citrus fruits like orange and lemon, which can irritate the stomach and increase acid secretion.
- Inform your doctor if you do not feel better after taking Lafutidine for 2 weeks as you may be suffering from some other problems.
- Inform your doctor if you have ever been diagnosed with kidney disease as dose of your medicine may need to be adjusted.
- Do not stop taking the medication without talking to your doctor.