Rozacal K2

Uses

Magnesium sulfate injection is used for the following conditions:

Convulsions (treatment) - Intravenous Magnesium sulfate injection is used for immediate control of life-threatening convulsions in the treatment of severe toxemias (pre-eclampsia and eclampsia) of pregnancy and in the treatment of acute nephritis in children.

Hypomagnesemia (prophylaxis and treatment) - Magnesium sulfate injection is used for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those of hypocalcemia.

Magnesium sulfate injection is also used to prevent or treat magnesium deficiency in patients receiving total parenteral nutrition.

Tetany, uterine (treatment) - Magnesium sulfate injection is used for uterine tetany as a myometrial relaxant.

Mecobalamin is used for-

• Peripheral Neuropathies
• Diabetic Neuropathy
• Verteberal Syndrome
• Nerve Compression Syndrome
• Multiple sclerosis
• Amyotrophic lateral sclerosis
• Parkinson’s disease
• Alzheimer’s disease
• Diabetic retinopathy
• Entrapment neuropathy
• Drug induced neuropathy
• Megaloblastic anemia due to Vitamin B12 deficiency

Zinc sulfate is a drug used to replenish low levels of zinc or prevent zinc deficiency, or to test for zinc deficiency.

This medication is a mineral used to treat or prevent low levels of zinc alone and together with oral rehydration therapy (ORT). It is also used as a topical astringent. Zinc Sulfate Injection, USP is indicated for use as a supplement to intravenous solutions given for TPN.

Rozacal K2 is also used to associated treatment for these conditions: Constipation, Convulsions, Hypomagnesemia, Torsades de Pointes, Barium poisoning, Severe Exacerbation of asthma, Bowel preparation therapy, Soaking aid for minor sprains and bruisesVitamin B12 Deficiency, Nutritional supplementationDry Eyes, Local itching, Localized pain, Localized swelling, Nutritional supplementation

How Rozacal K2 works

Magnesium is the second most plentiful cation of the intracellular fluids. It is essential for the activity of many enzyme systems and plays an important role with regard to neurochemical transmission and muscular excitability. Magnesium sulfate reduces striated muscle contractions and blocks peripheral neuromuscular transmission by reducing acetylcholine release at the myoneural junction. Additionally, Magnesium inhibits Ca²⁺ influx through dihydropyridine-sensitive, voltage-dependent channels. This accounts for much of its relaxant action on vascular smooth muscle.

Zinc inhibits cAMP-induced, chloride-dependent fluid secretion by inhibiting basolateral potassium (K) channels, in in-vitro studies with rat ileum. This study has also shown the specificity of Zn to cAMP-activated K channels, because zinc did not block the calcium (Ca)-mediated K channels. As this study was not performed in Zn-deficient animals, it provides evidence that Zn is probably effective in the absence of Zn deficiency. Zinc also improves the absorption of water and electrolytes, improves regeneration of the intestinal epithelium, increases the levels of brush border enzymes, and enhances the immune response, allowing for a better clearance of the pathogens.

Dosage

Rozacal K2 dosage

Intramuscular:Adults and older children: For severe hypomagnesemia, 1 to 5 g (2 to 10 mLof 50% solution) daily in divided doses; administration is repeated daily until serum levels have returned to normal. If deficiency is not severe, 1 g (2 mL of 50% solution) can be given once or twice daily. Serum magnesium levels should serve as a guide to continued dosage.

Intravenous:1 to 4 g magnesium sulfate (magnesium sulfate (magnesium sulfate injection) injection) may be given intravenously in 10% to 20% solution, but only with great caution; the rate should not exceed 1.5 mL of 10% solution or equivalent per minute until relaxation is obtained.

Intravenous Infusion:4 g in 250 mL of 5% Dextrose Injection at a rate not exceeding 3 mL per minute.

Usual Dose Range:1 to 40 g daily.

Electrolyte Replenisher:Intramuscular 1 to 2 g in 50% solution four times a day until serum magnesium is within normal limits.

Usual Pediatric Dose:Intramuscular 20 to 40 mg per kg of body weight in a 20% solution repeated as necessary.

For Eclampsia:Initially 1 to 2 g in 25% or 50% solution is given intramuscularly. Subsequently, 1 g is given every 30 minutes until relief is obtained. The blood pressure should be monitored after each injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Tablet: The usual adult dosage is one 500 mcg tablet three times daily. The dosage should be adjusted according to the age of patient and the severity of symptoms.

Injection:

• Peripheral neuropathies: The usual adult dosage is one ampoule equivalent to 500 mcg of Mecobalamin, administered intramuscularly or intravenously three times a week.The dosage should be adjusted according to the age of patient and the severity of symptoms.
• Megaloblastic anemia: The usual adult dosage is one ampoule equivalent to 500 mcg of Mecobalamin, administered intramuscularly or intravenously three times a week. After about two months of administration, dosage should be changed to one ampoule equivalent to 500 mcg of Mecobalamin every one to three months as maintenance therapy

Side Effects

Flushing, sweating, sharply lowered blood pressure, hypothermia, stupor and ultimately, respiratory depression.

Generally Mecobalamin is well tolerated. However, a few side effects like GI discomfort (including anorexia, nausea or diarrhea) & rash may be seen after administration of Mecobalamin.

Toxicity

LD₅₀ = 1200 mg/kg (rat, subcutaneous). May be harmful if swallowed. May act as an irritant. Adverse reactions include hypotension, ECG changes, diarrhea, urinary retention, CNS depression and respiratory depression.

Human : TDLo ( Oral) 45mg/kg/7D-C : Normocytic anemia, pulse rate increase without fall inBP Human: TDLo (oral) 106mg/kg : Hypermotylity, diarrhea Mouse ; LD50 Oral : 245mg/kg Mouse : LD50 : subcutaneous : 781mg/kg

Precaution

Renal impairment, myasthaenia gravis, digitalised patients; pregnancy. Monitor serum-magnesium concentrations.

The medicine should not be used for months if there is no response at all after its use for a certain period of time.

Interaction

Decreased GI tract absorption with neomycin, aminosalicylic acid, H2-blockers and colchicine. Reduced serum concentrations with oral contraceptives. Reduced effects in anaemia with parenteral chloramphenicol.

Volume of Distribution

After absorption zinc is bound to protein metallothionein in the intestines. Zinc is widely distributed throughout the body. It is primarily stored in RBCs, WBCs, muscles, bones, Skin, Kidneys, Liver, Pancreas, retina, and prostate.

Elimination Route

Approximately 20 to 30% of dietary zinc is absorbed, primarily from the duodenum and ileum. The amount absorbed is dependent on the bioavailability from food. Zinc is the most bioavailable from red meat and oysters. Phytates may impair absorption by chelation and formation of insoluble complexes at an alkaline pH. After absorption, zinc is bound in the intestine to the protein metallothionein. Endogenous zinc can be reabsorbed in the ileum and colon, creating an enteropancreatic circulation of zinc.

Half Life

43.2 hours (for newborns)

3 hours

Elimination Route

Magnesium is excreted solely by the kidney at a rate proportional to the serum concentration and glomerular filtration.

Primarily fecal (approximately 90%); to a lesser extent in the urine and in perspiration.

Pregnancy & Breastfeeding use

Pregnancy category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Not recommended during pregnancy & lactation.

Contraindication

Heart block, severe renal impairment, myocardial damage.

Hypersensitivity to any component of this product.

Special Warning

Use in children: Not recommended.

Acute Overdose

Symptoms of hypermagnesaemia are: respiratory depression and loss of deep tendon reflexes due to neuromuscular blockade; nausea, vomiting, flushing, thirst, hypotension, drowsiness, confusion, slurred speech, double vision, bradycardia and muscle weakness.

Treatment in adults should include IV administration of 5-10 mEq of 10% calcium gluconate. Artificial respiration may be required.

Storage Condition

Oral: Store at room temperature. Protect from moisture and light.

Parenteral: Store at room temperature. Do not expose to direct light.

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