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Norit

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Norit® Capsules 200mg

Norit® Capsule is indicated as gastrointestinal adsorbent in the treatment of acute diarrhea, flatulence and mild food poisoning. Its active ingredient—activated charcoal is officially indicated for detoxification in which it adsorbs the poison in the gastrointestinal tract and blocks its absorption into the systemic circulation.
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PHARMACOPOEIA-GRADE
  • The only activated charcoal-containing medicinal product in the world meeting the USP and EUP specifications for absorption-efficacy tests.

SAFE & EFFECTIVE
  • Safe for human consumption.
  • Effective in removing various gastrointestinal contaminants.

RIGHT PORES SIZE FOR MAXIMUM ADSORPTION

The enormous surface area created in Norit® Activated Charcoal is the result of the proprietary technology which enables the ability to control and create the correct pore size needed for maximal adsorption for drugs, toxins, bacteria, viruses, toxic metabolic agents and other unwanted physiological substances.

Normal Charcoal
Activated Carbon

COMPOSITION: Each capsule contains 200 mg Activated Charcoal as active ingredient.

PRODUCT DESCRIPTION: Norit capsules contains activated charcoal which is a fine, black, insoluble powder without taste or odor in black hard gelatin capsule that has a unique shorter and wider shape.

ROUTE OF ADMINSTRATION: Oral

PHARMACODYNAMICS:
Mechanism of Action: Activated charcoal is obtained by destructive distillation of organic material, coconut shells (which contain high carbon content and low ash and tar content), which are then ‘activated’ by exposing it to oxidizing STEAM at approximately 1000ºC high temperature (in depleted oxygen environment), resulting in the production of vastly increased surface area from the creation of pores (with controlled pore size). The drug has the ability to adsorb a wide variety of substances onto its surface. This property can be applied in preventing the absorption of various harmful substances, which are responsible for diarrhea cases (traveler’s disease), from the gastrointestinal tract and various drugs and toxicants involved with oral poisonings. Norit activated charcoal has fulfilled the requirements of USA/ European Pharmacopoeia for its adsorption capacity of ≥38% vs methylene blue and ≥ 40% phenazone respectively (the references test compounds in both respective pharmacopoeia).
Adsorption of substances onto charcoal is a reversible process with rapid adsorption and slow resorption. The rate of adsorption depends on the particle size, viscosity of the medium, pH (acids and bases) and the amount and type of gastrointestinal contents.

PHARMACOKINETICS:
Since activated charcoal is not absorbed from the gastro intestinal tract, there is no distribution phase nor any metabolism. The complex between activated carbon and the adsorbed compounds may only be passed in the stool. Norit activated charcoal is compliance with ICH Q3D guidelines on elemental impurities.

INDICATIONS:
Norit is indicated as gastrointestinal absorbent in the treatment of acute diarrhea, flatulence (excessive gas in the stomach and/or intestine) and mild food poisoning.

DOSAGE:
Diarrhea & Flatulence: 3 capsules 3-4 times a day; 12 capsules is the maximum dose per day. Children’s dosage is half of adult’s.
Mild food poisoning: 3 to 5 capsules repeated 3 to 4 times daily. Children’s dosage is half dosage of adult dose.
The capsules should be taken with water orally.

DRUG INTERACTIONS:
The use of activated charcoal will generally reduce the effect of oral medicines. Activated charcoal has the potential to reduce the absorption of many drugs from the gastrointestinal tract and simultaneous oral therapy should therefore be avoided.
To prevent this interaction, take activated charcoal at least 2 hours after medication taken orally.

CONTRAINDICATIONS:
Total gastro intestinal obstruction, suspected ileus, acute abdominal pain and ulcerative colitis.

WARNINGS & PRECAUTIONS:
1) The use of activated charcoal will cause the feces to be black.
2) Diarrhea: In case of persisting diarrhea after three days of treatment, consult a doctor for additional clinical and biochemical investigations.
3) Oral rehydration therapy which is the use of appropriate fluids including oral rehydration salts remains the most effective treatment for dehydration due to diarrhea. The intake of as much of these fluids as possible is therefore imperative.
4) Treatment of diarrhea in children under 6 years of age should be under medical supervision.

PREGNANCY & LACTATION:
This medicine can, as far as is known, be used as prescribed during pregnancy and breastfeeding without any danger for the foetus or the child.

SIDE EFFECT:
Activated charcoal is relatively non-toxic when given by mouth but gastrointestinal disturbances such as vomiting and constipation have been reported.
It may colour the faeces black

SYMPTOMS & TREATMENT OF OVERDOSE:
Higher dosage or long time administration may cause nausea and constipation requiring the administration of laxative.

STORAGE CONDITION:
Store in the original package, in order to protect from moisture. Keep away from direct sunlight and store at temperature between 15-30 ºC

SHELF LIFE:
5 years at 15-30 ºC stored in PVC / blister strips after date of production.

DOSAGE FORMS AND PACKAGING AVAILABLE:
30 capsules per box

Manufactured by:
Cabot Norit Nederland B.V.
Mr. Ovingkanaal O.Z. 3,
7891 EV Klazienaveen,
The Netherlands

Imported & Distributed by:
Ubisson Sdn. Bhd. (585048-H)
No. 35, 1st & 3rd Floor, Pusat Pedada,
Jalan Pedada, 96000 Sibu, Sarawak, Malaysia.
Tel: +6084-333858
Fax: +6084-311688
Email: office.ubisson@gmail.com

Activated Charcoal

ACTIVATION process of carbon molecules effectively forms fine networks of interlocking minuscule pores which increase the internal surface area of the resulting activated charcoal tremendously.
The resulting increase in surface area determines:
a) The adsorption power of the activated charcoal
b) The pore size distribution (to suit the intended filtrate molecular size for industrial or pharmaceutical purpose)

How does Activated Charcoal works?

Activated charcoal adsorbs substances by physical forces and ‘traps’ these adsorbed substances in its fine network of interlocking pores. 

Medical Use of Activated Charcoal

a) Drug of First Choice in case of Non-specific acute diarrhea. (with ORS)
b) Flatulence
c) Mild / moderare Food Poisoning

First Choice in Treatment of Acute Diarrhea:
Why NORIT Activated Charcoal?

a) STOPS diarrhea
b) PURIFIES the intestines by adsorbing impurities and unwanted harmful substances.
c) CURES and deal with the cause of the diarrhea.

*Loperamide and / or Lomotil which only stops the diarrhoea by stopping the normal functioning of the GIT peristalsis system. Contra-indicated for young children. Food Poisoning and infectious diarrhea.

NORIT Activated Charcoal takes care of a Natural Purification Effectively.
Dorn 2004: To identify the efficacy and tolerance of activated charcoal in acute non specific diarrhea

Conclusion

NORIT Activated Carbon proved an effective, rapid and reliable treatment of acute diarrhea and is very well tolerated.

  • No side effect and contra-indications
  • Safe for all age groups
In Most Patients treated with activated carbon the intestines are purified within 2 or 3 days and the diarrhea stops
Why Norit Activated Charcoal is special?

1. The ONLY medicinal grade that conforms to US and European Pharmacopoeia Grade
a. Reliable and effective
b. Pharmacopoeia grade ensures safe human consumption.

2. Easy to swallow / No black teeth
a. No need to chew and no chalky feeling

3. Fast onset of action
a. Pure Powder form – fast dispersion

4. Highest Potency
a. No excipient
b. Achieve Phenazone Adsorption 54% (Eur Pharmacopoeia Minimum requirement is at least 40% and above)

Other therapeutic indications

Hypercholesterolaemia
A Finnish study has shown that the blood cholesterol levels of patients suffering from hyper-cholesterolaemia was reduced by 25% following the administration of activated carbon. The LDL-cholestrol level was reduced by at least 41% (The LDL = Low-Density Lipoprotein binds with newly made cholesterol. A high LDL level means a high blood cholesterol level). The HDL level increased by 8% (The HDL = High Density Lipoprotein binds the cholesterol that is broken down in the body. A high HDL level means that the cholesterol level in the blood will be reduced). No significant side effects were reported.

Hangovers
Some constituents of alcoholic drinks form toxic products in the gastrointestinal tract and in the blood stream. This is the origin of the hangover, which is preventable if activated carbon is taken as a prophylactic measure. Even after drinking, activated carbon will treat the symptoms of the hangover quickly, by rapid adsorption of the toxics produced. As mentioned above, alcohol itself is only slightly adsorbed by activated carbon.

Weight Control
The use of Activated Charcoal in the early part of the 20th century in USA in treatment of ‘meteorism* (a tendency to uncontrollable flatulence) without success and definite harm caused from its long term continued use has clearly without doubt led to its deletion from the US Pharmacopoeia before its reinstatement in the 1960’s. By the 1960’s, much more knowledge of activated charcoal is known that pharmacopoeia grade activated charcoal will not only adsorb toxins, but also vitamins, minerals, digestive enzymes, amino acids and other valuable nutrients from the gut. For these same reasons, there has been over a hundred patents for use in weight control using Pharmacopoeia Grade Activated Charcoal in the USA. (All brands of pharmacopoeia grade activated charcoal in the US have their raw material sourced from NORIT, USA)

CHARCOAL, ACTIVATED
Carbo Activatus

DEFINITION
Activated charcoal is obtained from vegetable matter by suitable carbonisation processes intended to confer a high adsorption power.

CHARACTERS
A black, light powder free from grittiness, practically insoluble in all usual solvents.

IDENTIFICATION
A. When heated to redness it burns slowly without a flame.
B. It complies with the test for adsorption power (see Tests).

TESTS
Solution S. To 2.0 g in a conical flask with a ground-glass neck add 50 ml of dilute hydrochloric acid R. Boil gently under a reflux condenser for 1 h, filter and wash the filter with dilute hydrochloric acid R. Evaporate the combined filtrate and washings to dryness on a water-bath, dissolve the residue in 0.1 M hydrochloric acid and dilute to 50.0 ml with the same acid.

Acidity or alkalinity. To 2.0 g add 40 ml of water R and boil for 5 min. Cool,
restore to the original mass with carbon dioxide-free water R and filter. Reject the first 20 ml of the filtrate. To 10 ml of the filtrate add 0.25 ml of bromothymol blue solution R1 and 0.25 ml of 0.02 M sodium hydroxide. The solution is blue. Not more than 0.75 ml of 0.02 M hydrochloric acid is required to change the colour of the indicator to yellow.

Acid-soluble substances. To 1.0 g add 25 ml of dilute nitric acid R and boil for 5 min. Filter whilst hot through a sintered-glass filter (10) and wash with 10 ml of hot water R. Evaporate the combined filtrate and washings to dryness on a water-bath, add to the residue 1 ml of hydrochloric acid 12, evaporate to dryness again and dry the residue to constantmass at 100 °C CO 105 °C. The residue weighs not more than 30 mg (3 per cent).

Alkali-soluble coloured substances. To 0.25 g add 10 ml of dilute sodium
hydroxide solution Rand boil for 1 min. Cool, filter and dilute the filtrate to 10 ml with water R. The solution is not more intensely coloured than reference solution GY4 (2.2.2, Method 11).

Alcohol-soluble substances. To 2.0 g add 50 ml of alcohol R and boil under a reflux condenser for 10 min. Filter immediately, cool, and dilute to 50 ml with
alcohol R. The filtrate is not more intensely coloured than reference solution Y6 or BY6 (2.2.2, Methold I!). Evaporate 40 ml of the filtrate to dryness and dry to constant mass at 100 °C to 105 °C. The residue weighs not more than 8 mg (0.5 per cent).

Fluorescent substances. In an intermittent-extraction apparatus, treat 10.0 g with 100 ml of cyclohexane RI for 1 h. Collect the liquid and dilute to 100 ml with gdohexane RI. Examine in ultraviolet light at 365 nm. The fluorescence of the solution is not more intense than that of a solution of 83pg of quinine R in 1000 ml of 0.005 M sulphuric acid examined in the same manner.

Sulphides. To 1.0 g in a conical flask add 5 ml of hydrochloric acid RI and 20 ml of water R. Heat to boiling. The fumes released do not turn lead acetate paper R brown.

Copper. Not more than 25 ppm of Cu, determined by atomic absorption
spectrometry (2.2.23, Method 1).

Test solution. Use solution S.

Reference solutions. Prepare the reference solutions using copper standard solution (0.1 per cent Cu) R and diluting with 0.1 M hydrochloric acid.

Measure the absorbance at 325.0 nm using a copper hollow-cathode lamp as source of radiation and an air-acetylene flame.

Lead. Not more than 10 ppm of Pb, determined by atomic absorption
spectrometry (2.2.23, Method I).

Test solution. Use solution S.

Reference solutions. Prepare the reference solutions using lead standard solution (100 ppm Pb) R and diluting with 0.1 M hydrochloric acid.

Measure the absorbance at 283.3 nm using a lead hollow-cathode lamp as source of radiation and an air-acetylene flame. Depending on the apparatus the line at 217.0 nm may be used.

Zinc. Not more than 25 ppm of Zn, determined by atomic absorption spectrometry (2.2.23, Method 1).

Test solution. Use solution S.

Reference solutions. Prepare the reference solutions using zinc standard solution (100 ppm Zn) R and diluting with 0.1 M hydrochloric acid.

Measure the absorbance at 214.0 nm using a zinc hollow-cathode lamp as source of radiation and an air-acetylene flame.

Loss on drying. (2.2.32). Not more than 15 per cent, determined on 1.00 g by drying in an oven at 120 °C for 4 h.

Sulphated ash. (2.4.14). Not more than 5.0 per cent, determined on 1.0 g.

Adsorption power. To 0.300 g in a 100 ml ground-glass-stoppered conical flask add 25.0 ml of a freshly prepared solution of 0.5 g of phenazone R in 50 ml of water R. Shake throughly for 15 min. Filter and reject the first 5 ml of filtrate. To 10.0 ml of the filtrate add 1.0 g of potassium bromide R and 20 ml of dilute hydrochloric acid R. Using 0.1 ml of methyl red solution R as indicator, titrate with 0.0167 M potassium bromate until the red colour is discharged. Tttrate slowly (1 drop every 15 s) towards the end of the titration. Carry out a blank titration using 10.0 nil of the phenazone solution.
Calculate the quantity of phenazone adsorbed per 100 g of activated charcoal from the expression:

2.353 (a — b)
m
a = number of millilitres of 0.0167 M potassium bromate used for the blanks,
b = number of millilitres of 0.0167 M potassium bromate used for the test,
m = mass in grams of the substance to be examined.

Not less than 40 g of phenazone is adsorbed per 100 g of activated
charcoal, calculated with reference to the dried substance.

Microbial contamination. Total viable aerobic count (2.6.12) not more than 10′ micro-organisms per gram, determined by plate acount.

STORAGE
Store in an airtight container.

NORIT Carbomix is officially listed in MOH Drug
Formulary as: Charcoal, Activated 50g Granules
[A07BA01-000-F10-01-XX]

References: 1) Dorn. M. Controlled clinical testing of an antidiarrhoeal agent Fortschnitte der medizin 2:2004. 2) New formulation of Oral Rehydration Salts (ORS) with reduced osmolarity. Technical Bulletin. WHO 9: 2: 2004.

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