Brand : Digeraft XT
Molecule : Sodium alginate & Potassium hydrogen carbonate Oral Suspension
Dosage : 5-10 ml after meals and at bedtime

For the use of a Registered Medical Practitioner or a Hospital or Laboratory only

1.0 GENERIC NAME:
Sodium alginate and potassium hydrogen carbonate oral suspension.

BRAND NAME:
Digeraft XT

2.0 QUALITATIVE & QUANTITATIVE COMPOSITION:
Each 10 ml dose contains:
Sodium alginate IP 1000 mg
Potassium hydrogen carbonate Ph. Eur. 200 mg
In a flavored base………q.s.
Color: Erythrosine

3.0 DOSAGE FORM & STRENGTH:
Oral Suspension

4.0 CLINICAL PARTICULARS:

4.1 THERAPEUTIC INDICATION
To treat the symptoms of gastro-esophageal reflux during concomitant treatment with or
following withdrawal of acid suppressing therapy.

4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children 12 years and over: 5-10 ml after meals and at bedtime (one to two 5
ml measuring spoons).
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modification is required for this age group.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary

4.3 CONTRAINDICATIONS
This medicinal product is contraindicated in patients with known or suspected
hypersensitivity to the active substances or to any of the excipients.

4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms do not improve after 7 days, the clinical situation should be reviewed.

This medicinal product contains 106 mg (5.0 mmol) sodium per 10 ml dose, equivalent to
5.3% of the WHO recommended maximum daily intake for sodium.

The maximum daily dose of this product is equivalent to 21% of the WHO recommended maximum daily intake for sodium.

This product is considered high in sodium.This should be particularly taken into account for those on a low salt diet (e.g. in some cases of congestive heart failure and renal impairment).

Potassium: This medicine contains 78 mg (2.0 mmol) potassium per 10 ml dose. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

4.5 DRUG INTERACTIONS
A time-interval of 2 hours should be considered between Digeraft XT intake and the
administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron
salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.

4.6 USE IN SPECIAL POPULATIONS (SUCH AS PREGNANT WOMEN,LACTATING WOMEN, PAEDIATRIC PATIENTS, GERIATRIC PATIENTS ETC.)
Pregnancy:
Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor foeto/neonatal toxicity of the active substances. Digeraft XT can be used during pregnancy, if clinically needed.
Breast feeding:
No known effect on breast fed infants. Digeraft XT can be used during breast feeding.
Fertility:
No known effect on human fertility.

4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

4.8 UNDESIRABLE EFFECTS
Adverse reactions have been ranked under headings of frequency using 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) and not known (cannot be estimated from the available data).

4.9 OVERDOSE
Symptoms

Symptoms are likely to be minor; some abdominal discomfort may be experienced.

Management
In the event of overdose, symptomatic treatment should be given.

5.0 PHARMACOLOGIC PROPERTIES

5.1 Pharmacodynamic properties
On ingestion the suspension reacts with gastric acid to rapidly form a raft of alginic acid gel having a near-neutral pH which floats on the stomach contents quickly and effectively impeding gastro-oesophageal reflux for up to 4 hours, and protecting the oesophagus from acid, pepsin and bile. In severe cases the raft itself may be refluxed into the oesophagus in preference to the stomach contents and exert a demulcent effect. In addition in vitro evidence has shown that the raft has a secondary action and is able to entrap bile and pepsin within its structure, further protecting the oesophagus from these gastric components.

5.2 Pharmacokinetic properties
The mechanism of action of the medicinal product is physical and does not depend on
absorption into the systemic circulation

6.0 NONCLINICAL PROPERTIES

6.1 ANIMAL TOXICOLOGY OR PHARMACOLOGY
No pre-clinical findings of any relevance to the prescriber have been reported.

7.0 DESCRIPTION:
Light pink to pink colour suspension with mint flavor

8.0 PHARMACEUTICAL PARTICULARS

8.1 INCOMPATIBILITIES
Not applicable

8.2 SHELF-LIFE
Refer outer pack/carton.

8.3 PACKAGING INFORMATION
Round amber glass bottle with PP Plastic Cap containing 150ml

8.4 STORAGE/ HANDLING INFORMATION:
Store at a temperature not exceeding 30 degree Celsius. Do not refrigerate or freeze. Shake
well before use.

9.0 PATIENT COUNSELLING INFORMATION:
Inform patients of the potential for drug interactions. A time-interval of 2 hours should be considered between its administration of other medicinal products, especially tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroid hormones, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoid, chloroquine and bisphosphonates (diphosphonates) and estramustine.
Inform the patients about the necessary precautions when on a sodium restricted diet.

10. DETAILS OF MANUFACTURER:
Naxpar Pharma Pvt. Ltd.
182, Gurumajra, Kishanpura, Baddi, District Solan (HP) – 174101.

MARKETED BY:
Abbott India Limited
Angel Space, Bldg. No D4, Gala No 7 to 10 & 17 to 20 Gr. Floor, 107 to 110 & 117 to 120,First Floor Pimplas Village, Bhiwandi, District Thane, Tal: Bhiwandi – 16 (Thane Z5) 421302, Maharashtra, India

11. DETAILS OF PERMISSION OR LICENCE NUMBER WITH DATE
Manufacturing license no. MNB/07/617 dated 16.12.2021

12. DATE OF REVISION
Version 03; dated 26th July 2022

For product complaints and queries please write to webmasterindia@abbott.com

Approval code: IND2261878 20 Jan 2023