Nizatect 150 mg & 300 mg Hard Gelatin Capsule

Trade Name:  Nizatect

  • Hard Gelatin Capsule 150 mg.
  • Hard Gelatin Capsule 300 mg.

Generic Name: Nizatidine
Composition: Each hard Gelatin Capsule contains:

  • Active Ingredient: Nizatidine 150 mg Or Nizatidine 300 mg.
  • Inactive Ingredients: Pregelatinized Starch, Povidone K25, Maize starch, Magnesium stearate, Purified Talc.

Pharmaceutical Form: Hard Gelatin Capsule.

Pharmacological Action

Nizatect capsules
Nizatect capsules

Nizatect competes with histamine for binding at the H2 receptors on the gastric basolateral membrane of parietal cells. Competitive inhibition results in reduction of basal and nocturnal gastric acid secretions and lowers the amount of acid in the stomach and duodenum.This action helps to relieve the pain of heartburn and helps ulcers to heal including those caused by NSAIDS. By decreasing the production of stomach acid Nizatect can also be used to prevent ulcers from recurring. The drug also decreases the gastric acid response to stimuli such as food, caffeine, insulin, betazole or pentagastrin. Nizatidine had no demenstrable antiandrogenic action.

Indications 

Gastroesophageal reflux disease (GERD).

Gastric Ulcer, Duodenal Ulcer (active & for suppression).

Heartburn, acid indigestion, sour stomach due to over indulgence.

Dosage and usage

Active duodenal or benign gastric ulcer : 300mg daily at bed time or 150mg twice both for up to 8 weeks. Maintenance : 150mg daily at bedtime.

GERD: 150mg twice daily for up to 12 weeks.

Heartburn, acid indigestion, sour stomach due to over indulgence: 150mg daily.

The dose for patient with renal dysfunction should be reduced as follows: Active duodenal ulcer or benign gastric ulcer or GERD.

Creatinine clearance rate Dose
20-50 ml/min 150 mg daily
less than 20 ml/min 150 mg every other day
Maintenance Therapy
20- 50 ml/ min 150 mg evey other day
less than 20 ml/ min 150 mg every 3 days

Contraindications

NIZATECT should not be taken by people who are allergic to nizatidine or any ingredients of the medication or any H2-receptor antagonists (e.g., ranitidine, famotidine, cimetidine).

Side Effects

Abdominal pain, diarrhea, dizziness, gas, headache, indigestion, inflammation of the nose, nausea, pain, sore throat, vomiting, weakness.

Drug Interactions

  • No interactions have been observed between NIZATECT and theophylline, chlordiazepoxide, lorazepam, lidocaine, phenytoin and warfarin .
  • NIZATECT does not inhibit the cytochrome P-450-linked drug metabolizing enzyme system; therefore drug interactions mediated by inhibition of hepatic metabolism are not expected to occur.
  • In patients given very high doses (3900mg) of aspirin daily, increases in serum salicylate levels were seen when NIZATECT 150mg b.i.d was administered concurrently.

Pregnancy and Lactation

  • NIZATECT should be used during pregnancy only if clearly needed.
  • NIZATECT is excreted in breast milk . Do not breast-feed while taking NIZATECT.

Precautions and warnings

  • Tell your doctor if you have any pre-existing liver disease, kidney disease or any allergies including any drug allergies .
  • Smoking may cause intestinal problems (e.g.ulcer) to re-occur, hindering the effects-of this medication.
  • Elderly persons may be more sensitive to the effects of this medication.
  • Tell your doctor if you are pregnant before using this drug.
  • NIZATECT is excreted in breast milk. So consult your doctor before breast-feeding.

Storage and Package

  • Store at temperature not exceeding 30°C in a dry place.
  • Carton box containing 1,2,3 or 4 strips (AL/PVC) each of 10 capsules & insert leaflet.

Instruction To Patients

  • Do not take any new medication during therapy unless approved by doctor.
  • Take as directed; do not change dose or discontinue without consulting prescriber.
  • Give this medicine at bedtime with or without food. Give with food if it causes an upset stomach .
  • Do not take within 1 hour of any antacids. Follow diet instructions of prescriber.
  • May cause drowsiness ; use caution when driving or engaging in tasks that require alertness until response to drug is known.
  • Inform prescriber if you are or intend to become pregnant.

Manufactured by : Marcyrl Pharmaceutical Industries El Obour City – Egypt.

-- Arabic Information
Nizatect capsules- Arabic Information

Nizatect- Information Leaflet

AR- Patient_Information_Leaflet
Nizatect capsules: AR- Patient_Information_Leaflet
ENG-Patient-Information-Leaflet
Nizatect capsules: ENG-Patient-Information-Leaflet

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