Contents

Phyllanthus niruri L. extr

Indication

Enhance body immune system components in conditions such as tuberculosis, upper respiratory tract infection, chronic hepatitis B infection, herpes zoster infection, varicella infection in children and vaginal candidiasis.Potential Usage: Relating to the mechanism and effect of Stimuno for the immune system, it is concluded that Stimuno has potential in: Terminating diseases at its incubation stage: Stimuno optimizes the ability of immune system components during incubation period of infection caused by bacteria, virus, fungus and parasite infestation, so that the body could terminate the development of the disease at its incubation stage. Preventing illnesses aggravation and accelerating recovery time: Stimuno has the potential to prevent illness aggravation and accelerate recovery time on diseases, caused by bacterial, virus, fungus, infectious parasites and cancer.

Dosage / Direction For Use

Cap: Adult: 3 capsules daily.Syrup: Adult: 2 measuring teaspoonfuls (10 mL) 3 times daily. Children older than 1 year: 1 measuring spoonful (5 mL), 3 times a day.

Overdosage

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Administration

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Contraindication

Hypersensitivity to Phyllanthus niruri L. extract and patients suffering from autoimmune disease.Syrup: WIth the formulations and dosage used, no contraindication has been reported.

Special Precaution

To be effective, the herb must be taken regularly for a month or longer.At customary dosage levels, no side effects have been reported.

Adverse Reactions

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Drug Interaction

Pharmacokinetic Interaction: Currently no data is available on its pharmacokinetic interaction with other medications.Pharmacodynamic Interaction: Stimuno has a synergistic interaction with antimicrobial medications to accelerate microbe infection therapy. There is antagonist interaction with corticosteroid medications due to Stimuno’s ability as an immunostimulant agent, while on the other hand, corticosteroids act as immunosuppressant agents.

Storage

Store at temperatures not exceeding 30°C. Protect from light.Shelf-Life: 36 months.

Description

Each measuring spoonful (5 mL) contains: Phyllanthus niruri L. herbal extracts 25 mg.STIMUNO is made from standardized herbal extract of Phyllanthus niruri (Meniran) which has gone through preclinical and clinical studies. As an immunomodulator (modulates the immune system), STIMUNO helps our body to produce more antibodies and activates the immune system to work optimally.Phyllanthus niruri L. extract contains flavonoids eg, quercetrin, quercitrin, isoquercitrin, astragalin, rutin, nirurin; lignan consisting of phyllanthin, hypophyllanthin. Alkaloid mentioned as ent-norcecurinin. It also contains new lignan and isolignan eg, lintetralin, isolintetralin, nirtetralin, nirphyllin.

Action

Introduction: Stimuno is made from extract of Phyllanthus niruri L. In some region in Indonesia, this plant is known as meniran. Since 2000 years ago, Phyllanthus niruri L. has been widely used as herbs in various countries in the world, one of them is ‘Ayurvedic Medicine/Ayurveda’ in India. The use of this plant is very broad, eg, for treating hepatitis, gonorrhea, urinary tract infections, stomachache, toothache, kidney stones, irregular period (menstruation), diabetes, dysentery and also as an antipyretic and diuretic.The genus of Phyllanthus comprises of some species, 2 of the most common species usually made into herbs are Phyllanthus niruri L. and Phyllanthus urinaria. Phyllanthus niruri L. has pale green stalks, whereas Phyllanthus urinaria has reddish stalks. In some countries, Phyllanthus niruri L. is known as Phyllanthus amarus, Phyllanthus debilis, Phyllanthus fraternus or Phyllanthus rotundifolius.The activity of the plant on immune system has been tested in several preclinical studies. Further preclinical studies in rats and mice were conducted to determine the safety and immunomodulatory characteristics of Phyllanthus niruri L. The results of the studies showed that the extract of Phyllantus niruri L. can modulate the immune system through proliferation and activation of T and B lymphocytes, secretion of specific cytokines eg, interferon-γ, TNF-α (tumor necrosis factor-α), interleukin and activation of complement system, phagocytes eg, macrophages and monocytes. In addition, the cytotoxic activity of natural killer (NK) cells is increased. Furthermore, several clinical studies have been conducted to assess immunomodulatory effects in some cases with certain conditions, eg, pulmonary TB (tuberculosis), hepatitis B, upper respiratory tract infections, herpes zoster, acute exacerbation of chronic obstructive pulmonary diseases (COPD) and vaginal candidiasis. From preclinical and clinical studies similar results were found in immunological parameter, which is P. niruri L. extract in Stimuno acts as immunomodulator, to strengthen the body immune system and increase success rate in infection therapy.Stimuno is the only immunomodulator with phytopharmaca certificate from Indonesian National Agency for Drug and Food Control. Phytopharmaca certificate is given only to herbal products, containing standardized extract, with efficacy proven by clinical trial, hence it shows comparable efficacy to synthetic drugs. Stimuno got the phytopharmaca certificate after going through 4 stages of trial, ie, 1st stage, preclinical trial to study the safety (ie, toxicity studies) and efficacy (ie, pharmacodynamic studies) in animals; 2nd stage, simple standardization of raw material; 3rd stage, pharmaceutical standardization to ensure the identity and standardization of finished goods; 4th stage, clinical trials in both healthy volunteers and patients. In conclusion, as phytopharmaca product, Stimuno is certified for its quality, safety and efficacy.Stimuno has been marketed since 1999 as prescribed product in Indonesia. Stimuno received good responses from doctors for its quality and safety. Since August 1st, 2005, Stimuno was switched to over-the-counter (OTC) allowing customers to buy from outlets without prescriptions. This new approach is welcome by customers as they have been aware on the efficacy and safety of the product since the prescription period.Pharmacology: Pharmacodynamics: Mechanism of Action: Stimuno activates both specific and non-specific immune system, and also both cellular and humoral immune system.