Re-Leaf/Re-Leaf Forte

Re-Leaf/Re-Leaf Forte

Manufacturer:

PPC

Distributor:

Zuellig
Full Prescribing Info
Contents
Sambong powdered leaves (Blumea balsamifera L.).
Description
RE-LEAF 250 mg Tablet: Each Tablet contains: Blumea balsamifera (L.) Sambong leaves 250 mg.
RE-LEAF 500 mg Tablet: Each Tablet contains: Blumea balsamifera (L.) Sambong leaves 500 mg.
The Plant: Kaliban (Tag.); Alibhon, Alimon, Dalapot, Lakdanbulan, Ayoban, Bukadkad, Gabuen, Gintin-gintin, Haliban, Kambihon, Lalakdan, (Visayas); Sobsob (Ilocos); Lakadbulan (Bicol); Labulan, Sambun (Sulu); Takamain (Bagobo); Blumea camphor, Ngai camphor (English).
We have captured nature's healing wonders through science. Sambong is the only scientifically studied anti-urolithiasis and diuretic herbal preparation in the Philippines today. The National Integrated Research Program on Medicinal Plants (NIRPROMP) has validated the ancient yet popular knowledge and practices of our traditional healers. They have established in both animal and human studies, the wide margin of safety and efficacy of Sambong as an anti-urolithiasis and diuretic medicine.
Sambong is a tall erect, half-woody herb growing up to 3 meters high. The leaf is green with a hairy underside and can have a diameter of 100 mm. Its stem is also densely hairy. It is abundant in all regions of the Philippines and grow in shady areas. Our herbs are nurtured organically in prime farms untainted by synthetic chemical fertilizers or pesticides.
Action
Pharmacology: Pharmacodynamics/Pharmacokinetics: There have been more than 100 volatile or non-volatile constituents isolated from Sambong, including monoterpenes, sesquiterpenes, diterpenes, flavonoids, organic acids, esters, alcohols, dihydroflavone, and sterols. L-borneol was the most abundant and active constituent in this plant. Studies of Sambong mainly focused on the volatile oils and flavonoids, which possessed various bioactivities in vivo and in vitro. In the Philippines, Sambong (Re-leaf) has been shown to have diuretic properties at 32-50 mg/kg BW in 3 divided doses comparable to that of thiazide producing significant chloriuresis and some potassium and sodium sparing effect. This showed that Sambong (Re-leaf) may act along more than one segment of the nephron.
A local in-vitro study evaluating the chemolytic effects of Sambong (Re-leaf) in calcium stones revealed that at a maximal dose of 40 mg/kg/day, Sambong (Re-leaf) produced statistically significant stone dissolution, spontaneous stone passage, sandy urine and absence or decrease in size and number of stones on IVP or ultrasound which was probably attributable to limonene. Sambong (Re-leaf) also contains borneol which has tonic effect that promotes muscle relaxation and sesquiterpene which has an inhibitory property in the Ca-ATPase activity in the sarcoplasmic reticulum but the exact mechanism is unclear.
Another joint in-vitro study done by the U.P. Department of Pharmacology and the National Science and Technology Authority (now the Department of Science and Technology) in 1980 showed that Sambong (Re-leaf) decreased the frequency and amplitude of intestinal contractions and paralysis in higher doses, demonstrating its action as a smooth muscle relaxant. This property may explain the ability of Sambong (Re-leaf) to cause spontaneous stone passage despite the stone size affording dramatic pain relief in most patients. Comparing the in-vitro dissolution of calcium and uric acid stones, Sambong (Re-leaf) used at 20 mg/kg and 40 mg/kg was able to significantly reduce the weight of stones with a higher calcium oxalate content. Phase 2 and Phase 3 clinical studies using Sambong (Re-leaf) tablets at a maximal dose of 40 mg/kg/day for 6 weeks showed statistically significant radiographic evidences of decrease in size of stones and spontaneous stone passage, resulting to complete cure in the majority of patients.
The oral LD50 in mice of Sambong (Re-leaf) powdered leaves or tablets is 143.62 g/kg. Expressed juice, decoctions, powder, ethanol extract and tablets from Sambong (Re-leaf) leaves do not possess direct DNA damaging potential. No chromosome breaking effects were exhibited. However, these preparations reduced the genotoxicity of dimethylnitrosamine, methylmethanesulfonate, mitomycin c and tetracycline.
Indications/Uses
As anti-urolithiasis in patients with urinary tract stones with normal kidney function.
As diuretic in patients with mild to moderate congestive heart failure and edema.
Dosage/Direction for Use
As Diuretic: RE-LEAF 250 mg: 2 tablets 3 times a day.
RE-LEAF FORTE 500 mg: 1 tablet 3 times a day.
As Anti-urolithiasis: 40 to 50 mg/kg body weight per day in 3 equal doses.
Patients must also drink an additional 3 liters of water per 24 hours to prevent dehydration related to diuretic intake. Normal daily intake of water is 6-8 glasses/day.
Usual Adult Dose: RE-LEAF 250 mg: 4 tablets 3 times a day.
RE-LEAF FORTE 500 mg: 2 tablets 3 times a day.
Or as prescribed by the physician.
Overdosage
None reported in clinical trials.
Contraindications
There are no known contraindications.
Special Precautions
For patients with excretory urogram showing signs of renal obstruction, consultation with a physician is necessary. Safety in pregnant and lactating women has not been established.
Use In Pregnancy & Lactation
Insufficient data to recommend use among pregnant and lactating women.
Adverse Reactions
Reported adverse events include epigastric pain, constipation and flatulence.
Drug Interactions
No significant drug interactions documented.
Storage
Store at temperatures not exceeding 30°C.
Shelf-Life: 48 months (250 mg tablet) & 60 months (500 mg tablet).
ATC Classification
G04BX - Other urologicals ; Used in the treatment of urological problems.
Presentation/Packing
Re-Leaf: Tab 250 mg x 100's.
Re-Leaf Forte: Tab 500 mg x 60's.
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