Description and Composition of Unienzyme Tablets
Unienzyme with Methylpolysiloxane (MPS) is a unique combination of digestive enzymes- fungal diastase and papain plus nicotinamide, simethicone and activated charcoal for the symptomatic relief of indigestion.
Each sugar coated tablet of Unienzyme with MPS contains :
- Fungal Diastase (1:800) 20 mg
- Papain USP 30 mg
- Simethicone 50 mg
- Activated Charcoal BP 75 mg
- Nicotinamide BP 25 mg
These are its active pharmaceutical ingredients. In addition to these APIs, it also contains inactive ingredients called excipients in sufficient quantities.
Actions of Unienzyme Tablets
Enzyme preparations are useful as digestive aid in the treatment of patients deficiency of any of the enzymes required for the digestion of carbohydrates and proteins and therefore experience symptoms of indigestion. In such patients, there may be temporary decrease of enzyme secretions, leading to symptoms like dyspepsia, bloating, belching, flatulence and a feeling of abdominal fullness and discomfort.
Fungal diastase: It is an enzyme obtained from the growth of a strain of Aspergiilus oryzae. It contains two types of amylases namely, alpha amylase and beta amylase. These amylases have a high starch digesting action. The starch digesting capacity of fungal diastase in UNIENZYME with MPS tablets is 1:800, which means that Fungal diastase digests 800 parts of cooked starch that we may consume in the diet.
Fungal diastase also has some protease action and some lipase activity. This means that some digestive action is seen on proteins and fats.
Papain: It is a proteolytic enzyme or mixture of enzymes prepared from the juice of the unripe fruit of Carica Papaya. It consists chiefly of a mixture of papain and chymopapain, proteolytic enzymes which hydrolyse polypeptides, amides and esters especially at bonds involving basic amino acids or leucine or glycine yielding peptides of lower molecular weight. It assists in the digestion of proteins and its action is like that of the natural enzyme pepsin. The advantage of papain over pepsin is that it is active over a wide pH range of 3 to 10.5 as compared to pepsin (which is not active above a pH of 4.5). Papain, therefore is active in an acidic as well alkaline pH. Hence it is useful even in conditions of achlorhydria or hypochlorhydria. It is thus used as one of the ingredients in enzyme preparation to aid in protein digestion.
Nicotinamide: It is a member of the Vitamin B-complex group. It is used by the body as a source of niacin. Lipid metabolism, tissue respiration and glycogenolysis require nicotin. Nicotinamide functions in the body after conversion to either Nicotinamide adenine dinucleotide (NAD) or Nicotinamide adenine dinucleotide phosphate (NADP). NAD and NADP, the physiologically active forms, serve a vital role in metabolism as coenzyme for a wide variety of proteins that catalyse oxidation-reduction reactions essential for tissue respiration. It acts as a co-enzyme in the carbohydrate metabolism.
Simethicone or Methylpolysiloxane or MPS: The clinical use of simethicone is based on its anti-foaming properties. Simethicone lowers surface tension and when administered by mouth, allows mucus-surrounded gas bubbles in the GI Tract to coalesce and be expelled. Simethicone is physiologically inert and is not absorbed from the GI Tract nor does it interfere with gastric secretions or absorption of nutrients. It is for these properties that Simethicone is used as an adjunct with enzymes, for the symptomatic relief of flatulence, gastric bloating and belching. It is indicated for the relief of painful symptoms of excess gas in the digestive tract. It is used as an adjunct in the treatment of many conditions in which gas retention may be a problem, such as air swallowing, functional dyspepsia, peptic ulcer, spastic or irritable colon or diverticulosis.
Activated Charcoal : This is an adsorbent, detoxicant and soothing agent. Its porous surface adsorbs gas and poorly soluble substances. It reduces the volume of the intestinal gas and thereby produces relief from symptoms of flatulence and abdominal bloating. It is indicated for the relief of intestinal gas, diarrhea and GI distress associated with indigestion and accompanying cramps or odor.
Thus UNIENZYME with MPS has all the necessary ingredients that will assist in proper digestion of the principle nutrients like carbohydrates and proteins. Besides, it also helps in relieving the associated complaints of indigestion like bloating, belching, abdominal fullness and flatulence.
Indications and Uses of Unienzyme Tablets
Symptomatic relief in digestive disorders manifested by dyspepsia, bloating, belching, flatulence, abdominal discomfort or feeling of abdominal fullness, i.e. indigestion.
Contraindications
- Hypersensitivity to any of the ingredients.
- Activated charcoal is contraindicated when specific oral antidotes such as methionine are used.
- Nicotinic acid is contraindicated in hepatic dysfunction and active peptic ulcer.
Precautions
- Caution should be exercised during its use in pregnancy and lactation.
- Activated charcoal may colour the faeces black.
- Activated charcoal diminishes the action of ipecacuanha and other emetics when given concomitantly by mouth.
- Activated charcoal has the potential to reduce the absorption of many drugs from the gastro-intestinal tract and simultaneous oral therapy should therefore be avoided. Hence the preparation should be taken 2 hours before or 1 hour after other medication.
- Nicotinic acid should be given cautiously to patients with a history of peptic ulcer disease and to patients with diabetes mellitus, gout or impaired liver function.
- There may be an increased risk of myopathy or rhabdomyolysis when nicotinic acid is used concurrently with statins.
- Nicotinic acid may increase requirement for insulin or oral hypoglycemics.
Adverse Reactions of Unienzyme Tablets
Allergic/hypersensitivity or idiosyncratic reactions may occur. Flushing, pruritus, GI distress, activation of peptic ulcer nausea, vomiting, abdominal pain, diarrhea, sensation of warmth, skin rash, dry skin, itching, tingling, hypotension, transient headache, atrial fibrillations and other cardiac arrhythmias, decreased glucose tolerance have been reported with high doses of nicotinic acid. These effects are however transient in nature and will usually subside with continued therapy.
Dosage and Administration of Unienzyme Tablets
Use Unienzyme Tablets as directed by the physician.
Unienzyme Tablets Overdosage and Its Treatment
In the event of overdosage, supportive and symptomatic therapy is indicated.
How to Store Unienzyme Tablets
Store at temperature not exceeding 25ºC, protected from light & moisture.
Presentation of Unienzyme Tablets
Strip pack of 10 Tablets