Description

Dudo Herbal Mixture is indicated for Malaria and Loss of Appetite

NAME OF PRODUCT: Dudo Herbal Mixture

DOSAGE FORM: Decoction ACTIVE INGREDIENTS: Nauclea latifolia, Phyllanthus fraternus EXCIPIENTS: sodium Benzoate

INDICATION: This product is indicated for Malaria and Loss of Appetite.

DOSAGE AND ADMINISTRATION Route of Administration:

Dudo Herbal Mixture  must be taken orally.

Dosage Adults (18 years and above) The usual dose is; Three (3) tablespoonful (45ml) three times (3X) daily for Seven (7) days. Children (12 years to 17 years) Two (2) tablespoonfuls (30ml) three times (3X) daily for seven (7) days. If you forget to take a dose of Dudo Herbal Mixture, take the prescribed dose as soon as you remember and continue the rest of the dosage exactly as indicated above. Do not take double dose to make up for forgotten dose.

SIDE EFFECTS : Dudo Herbal Mixture is well tolerated. It has no Active ingredient known to cause drowsiness or dizziness. It therefore has no effect on driving or machinery operation.

WARNING / PRECAUTION Do not use Solak Herbal Mixture if:

– you are allergic to leaves, stem barks and roots of any of the Active Ingredients.

– your condition has not been diagnosed as Malaria or Loss of Appetite

-you have been diagnosed as an ulcer patient.

Please inform your prescriber you are taking Soladex Herbal Mixture, when other drugs are going to be prescribed for you, including allopathic over-the-counter-medicines.

CONTRAINDICATIONS Dudo Herbal Mixture is not recommended for pregnant women, lactating mothers and individuals below twelve (12) years.

INTERACTION WITH FOOD AND DRUGS Dudo Herbal Mixture is well tolerated with food and should be taken preferably after meals. Please consult your doctor or Health Provider if you are taking any other medicines

OVER-DOSAGE AND MANAGEMENT.

If you take overdose of Dudo Herbal Mixture, drink plenty of water and consult your Health Care Provider immediately.
Do not induce vomiting. The Observable Adverse Effect Level (OAEL) of Dudo Herbal Mixture is greater thean five times (5X) the stated daily dose.

STORAGE AND HANDLING; Store Dudo Herbal Mixture in a cool dry place away from direct sunlight.

CLINICAL PHARMACOLOGY Efficacy, Acute and Sub-Chronic Toxicity Test Establishment of Antiplasmodial Activity Anti-plasmodium activity of Dudo Herbal Mixture was assessed using an in vitro plasmodium inhibition assay. Plasmodium cultures were treated with selected concentrations of Dudo Mixture, Artesunate (reference antimalarial), and normal saline (Table 1) in a 24-well microtitre plates and incubated for 72 hours at 37°C.

Table 1.

Thin blood smears were prepared on properly labeled slides. The blood smears were air dried and fixed in methanol. The dried slides were Giemsa stained and observed with 100x microscopic lens in immersion oil using a light microscope. Growth inhibition due to treatment with Soladex Mixture and the reference antimalarial was calculated.

Total parasitaemia over the 48 h period was calculated in arbitrary unit as the area under the curve (AUC). Doses and concentrations responsible for 50% of the maximal effect (ICs, ) for each dose of Soladex Mixture and Artesunate were determined.

TOXICITY TEST Toxicity test on Dudo Herbal Mixture No. of animals sex/group e- 25 males 5 groups (N=5) Route Formulatio Time of Deaths and of ns and period of Observation admin. Dosage Oral Freeze- dried sample 30,10,100, 30 days 300, mg/kg NOAEL No death occurred >100 during the period of mg/kg observation; 24 h, and Sympto ms Nil NOAEL; No-Observable-Adverse-Effect Level.

REMARKS Dudo Mixture significantly reduces plasmodium falciparum from tissue and hence could be effective in relieving the symptoms of uncomplicated malaria. It also has an immune system boosting effect. The OAEL is greater than five times the stated daily dosage indicated. The recommended dose is thus with acceptable margin of safety.

PHYTOCHEMICAL PROPERTIES: Major chemical constituents in Dudo Herbal Mixture include; Reducing Sugars, Saponins, Tannins, Alkaloids and flavonoids. PHYSICOCHEMICAL DATA: PH (aq. Extract) 6.21 AVERAGE WT PER ML—-1.0396 gm/ml DRY WT PER ML——– 0.0664gm/ml

DETAILS OF MANUFACTURER: PRODUCED IN GHANA BY; SOLAK BIOCHEMIST P.O. BOX SE 788, SUAME-KUMASI. LOCATION: PLOT P54 ESRESO-ADAGYA, KUMASI TELEPHONE: 0261736263, 0245616028