OPT-D Capsule Benefits and Dosage

Opt-D capsules Description:

 Opt-D capsules are a dietary supplement that contains Cholecalciferol, a potent form of Vitamin D3. Vitamin D is a fat-soluble vitamin that plays a crucial role in regulating calcium and phosphorus levels in the body, which are essential for healthy bones, teeth, and muscle function. Cholecalciferol is a precursor of Calcitriol, an active hormone that helps the body absorb and utilize calcium efficiently. The chemical formula of Cholecalciferol is (3B, 5Z, 7E)-9, 10-secocholesta-5, 7, 10(19)-trien-3-ol, and it is known for its high bioavailability and effectiveness in maintaining optimal Vitamin D levels in the body. Opt-D capsules are a convenient and reliable way to supplement your daily intake of this essential nutrient.

SUPPLEMENT FACTS

 Opt_D Capsule 25,000 IU

Each oral soft gel capsule contains: Cholecalciferol (Vitamin D3). equivalent Opt_D Capsule 25,000 IU.

 Opt_D Capsule 100,000 IU

Each oral soft gel capsule contains: Cholecalciferol (Vitamin D3)..equivalent to 100,000 IU.

 Opt-D Capsule 200,000 IU

Each oral soft gel capsule contains: Cholecalciferol (Vitamin D3)..equivalent to 200,000 IU.

1 Worldwide unit [ IU ] of vitamin_D is comparable to 0.025mcg of Cholecalciferol 

 CLINICAL PHARMACOLOGY:

 Mechanism of Action

 Cholecalciferol, the active ingredient in Opt-D capsules, is produced naturally within the skin when it is exposed to ultraviolet (UV) radiation, such as sunlight. Once synthesized, cholecalciferol plays a crucial role in regulating calcium and phosphate homeostasis in the body by stimulating their absorption from the diet and promoting their incorporation into the bones.

In the small intestine, cholecalciferol enhances the uptake of both calcium and phosphate, both through passive and active transport mechanisms. This leads to an increased availability of these essential minerals for various physiological processes, including muscle function and nerve transmission.

In the kidneys, cholecalciferol acts by inhibiting the excretion of calcium and phosphate, thus conserving these minerals in the body. This is achieved by promoting tubular resorption of calcium and phosphate, which is facilitated by the biologically active form of cholecalciferol.

Moreover, cholecalciferol directly inhibits the production of parathyroid hormone (PTH) in the parathyroid glands. PTH plays a critical role in regulating calcium and phosphate levels in the body, and its excessive production can lead to various bone disorders, such as osteoporosis. By inhibiting PTH secretion, cholecalciferol helps maintain healthy bone metabolism and mineralization.

Overall, the mechanism of action of cholecalciferol in Opt-D capsules involves promoting the absorption and utilization of calcium and phosphate, conserving these minerals in the body, and regulating PTH production. This makes Opt-D capsules an effective supplement for maintaining optimal bone health and preventing various bone-related disorders.

Pharmacokinetics:

 Absorption Cholecalciferol from nutritional sources is almost completely absorbed from within the gastro-intestinal tract in the presence of dietary lipids and bile acids.

 Distribution & Metabolism:

 Cholecalciferol, the active ingredient in Opt-D capsules, is stored primarily in fat cells throughout the body. It undergoes metabolism by the microsomal hydroxylase enzyme to form 25-hydroxycholecalciferol (25(OH) D-3 or calcidiol), which is the primary storage form of Vitamin D-3 in the body.

In the kidneys, 25(OH) D-3 undergoes a secondary hydroxylation to form the most active metabolite, 1,25-dihydroxycholecalciferol (1,25(OH)2D3 or calcitriol). This metabolite plays a critical role in regulating calcium and phosphate homeostasis, promoting bone health and muscle function, and modulating the immune system.

Both the primary and active metabolites of cholecalciferol circulate in the blood bound to a specific alpha-globin protein, which helps transport them to their target tissues.

Following a single oral dose of cholecalciferol, the maximum serum concentrations of the primary storage form (25(OH) D-3) are typically reached after approximately 7 days. The metabolism and excretion of cholecalciferol and its metabolites occur primarily through the liver and kidneys, with excess amounts being excreted in the feces.

Overall, the distribution and metabolism of cholecalciferol involve its storage in fat cells, metabolism to its active form in the kidneys, and circulation in the blood bound to a specific protein. This makes cholecalciferol an essential nutrient for maintaining optimal calcium and phosphate levels in the body and promoting overall health and wellbeing.

 Elimination

 Cholecalciferol and its metabolites excreted mainly in_bile and faeces. 25(OH) D-3 is slowly eliminatéd with an apparent half_life in serum of about 50, days.

 INDICATIONS:

 Opt-D (Cholecalciferol) capsules are indicated in:

 • Prevention of Vitamin D deficiency

• Treatment of Vitamin D deficiency

• Osteomalacia due to hepatobiliary disease

• Osteomalacia due to malabsorption

 •Hypoparathyroidism

 • Osteodystrophy

 DOSAGE AND ADMINISTRATION:

 Adult dosage:

 Prevention of Vitamin-D deficiency: 25,000 IU capsule/ month

 Higher dose may be needed in certain population example: hospitalized individuals, dark

skinned individuals, individuals with limited effective sun exposure, obese individuals, patients being evaluated for osteoporosis, patients using certain concomitant medications (e.g., anticonvulsant medications, glucocorticoids), patients with malabsorption, including inflammatory bowel disease and coeliac disease. In such populations monitoring of serum Vitamin D levels 25(OH)D is also recommended.

 Treatment of Vitamin D deficiency:

 50000_IU 2 softgel capsules of 25000_IU per week initially for 7 weeks. Followed by maintenance therapy with 2 capsules of 25,000 IU per month.

 OR

 1 softgel of 100000,IU once every three months.

measuring 25(OH)D levels should be repeated about three to four months after starting maintenance therapy in order to confirm that the target level has been reached.

 Osteomalacia due to hepatobiliary disease:

 50000_IU 2 softgel capsule of 25000_IU once daily.

 Osteomalacia due to malabsorption:

 50000IU 2 capsules of 25000IU once daily

 Hypoparathyroidism:

Treatment of hypocalcemia of hypoparathyroidism initially, vitamin-D in oral dose of 50000 to 200000 units daily can be given as soon as acute tetany is controlled by intravenous calcium. Usual maintenance doses range from 25,000 to 100,000 units daily.

 Osteodystrophy:

 100,000-300,000 IU daily

 Dosing in adolescent patients 12-< 18 years of age:

 Prevention of Vitamin-D deficiency:

 1 capsule of 25,000 IU every 6 weeks

 Treatment of Vitamin D deficiency:

 I capsule of 25,000 IU once every 2 weeks for duration of 6 weeks Osteomalacia due to hepatobiliary disease:

 10,000 IU-25,000 IU daily

 Osteomalacia due to malabsorption:

 10,000 IU-25,000 IU daily

Dosing considerations in special populations

 Renal Impairment 

 No dosage adjustment required

 Hepatic Impairment No dosage adjustment required

 Administration requirements

 Swallowing OPT-D capsules orally should be done as evenly as possible throughout the day, preferably with a meal.

 CONTRAINDICATIONS

 Cholecalciferol must not be used in patients with:

• Many people are hypersensitive to the active substance (cholecalciferol) or any Vitamin D analogue.

• Hypercalcaemia and/or hypercalciuria Nephrolithiasis (Renal calculi)

• Hypervitaminosis D Severe renal impairment

• Metastatic calcification

 WARNING AND PRECAUTIONS

 Renal Impairment

Cholecalciferol, a type of vitamin D, should be used cautiously in patients with impaired renal function due to the potential exacerbation related to hypercalcemic effects during its therapeutic use. The impact on calcium and phosphate levels ought to moreover be checked The risk of soft tissue calcification should be taken into account.When people have serious kidney problems, their bodies may not process cholecalciferol (a type of vitamin D) correctly. So, doctors may need to use other types of vitamin D instead.

Hepatic Impairment

 In patients with liver impairment, Vitamin D absorption may be markedly impaired; conversion to active metabolite calcifediol may be reduced significantly, with the requirement of high doses of cholecalciferol. It's better to use medications that don't need the liver to break them down in this situation. If someone has a serious liver problem, it's not a good idea to use cholecalciferol as a treatment.

 Renal calculi

 Cholecalciferol should not be taken by patients with a tendency to form calcium-con- taining renal calculi.

 Cardiac disorders

 Caution are required in patients receiving treatment for cardiovascular diseases. There's a risk of potential compounding of cardiac disarranges and arteriosclerosis related to determined hypercalcemic impacts amid restorative utilize.

 Sarcoidosis

 Doctors need to be careful when prescribing cholecalciferol to patients with sarcoidosis, because there is a risk that their body might process vitamin D too quickly and turn it into its active form too soon. These patients ought to be checked with respect to the calcium substance in serum and pee.

 Serum calcium monitoring

 All patients receiving high, pharmacological doses of cholecalciferol and those with renal impairment should have their plasma calcium concentration monitored at intervals (initially once or twice weekly) and whenever nausea or vomiting occurs.

 Calcium supplementation

 Calcium supplementation should be considered for individual patients. Calcium supplement should given under medical supervision. Medical supervision during treatment is essential to prevent hypercalcemia.

 Risk of hypercalcemia due to concomitant medications

 Concurrent utilize of calcium-containing arrangements, other vitamin D-containing arrangements or vitamin D analogs, or thiazide diuretics with cholecalciferol may incline to (upgraded chance of hypercalcemia. See DRUG INTERACTIONS

 Hyperlipidemia

Cholecalciferol may cause a potential worsening of LDL height.

 Hyperphosphatemia

There's a risk of metastatic calcification; normalization of phosphate levels is shown earlier to treatment with cholecaciferol. 

 Effects on ability to drive and use machines Cholecalciferol has no known side effects that are likely to affect the ability to drive and use or operate machines.

ADVERSE REACTIONS

 Vitamin D3 (Cholcalciferol) is well-tolerated in therapeutic doses. Following adverse effects may occur however:

 Metabolism and nutrition disorders

 Uncommon: Hypercalcaemia, Hypercalciuria

 Skin and Subcutaneous disorders

 Rare: Pruritus, Rash, Urticaria

 Adverse effects observed with overdosage of Cholecalciferol (Hypervitaminosis - D) are given in OVERDOSAGE section.

 INTERACTIONS

Patients co-treated with cardiac glycosides along side cholecalciferol may be helpless to tall calcium levels and ought to have ECG parameters and calcium levels checked. It is suggested to reduce the measurements or hinder treatment in case the calcium substance within the pee surpasses 7.5 mmol/24 hours (300 mg/24 hours) 

Contemporaneous administration of benzothiadiazine derivations( thiazide diuretics) increases the threat of hypercalcaemia because they drop the calcium excretion in the urine. The calcium situations in tube and urine should thus be covered for cases witnessing long- term treatment.

If cholecalciferol is combined with metabolites or analogues of vitamin D careful monitoring of serum calcium situations is recommended. Anti-convulsantse.g. phenytoin, phenobarbital, primidone, carbamazapine may

• diminish thé effect of cholecalciferol due to hepatic enzyme induction. Hepatic enzymes are induced by cholecalciferol, which can increase the effect of this vitamin.

• Rifampicin may reduce the effective-ness öf cholecalciferol due to hepatic enzyme induction.

 • Isoniazid may diminish the viability of cholecalciferol due to hindrance of the metabolic actuation of cholecalciferol.

• Drugs driving to fat malabsorption, e.g. orlistat, fluid paraffin, cholestyramine, may impede the retention of cholecalciferol. 

 The cytotoxic agent actinomycin and imidazole antifungal agents interfere with vitamin D activity by inhibiting the conversion of 25-hydroxyvitamin D to 1,25-dihy- droxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase. Concomitant use of glucocorticoids can decrease the effect öf vitamin-D.

 USE IN SPECIAL POPULATIONS

 Pregnancy

 cholecalciferol during pregnancy/gestation are unlikely to_be harmful. However, Cholecalciferol should not be used during pregnancy unless the clinical condition of the woman requires treatment with cholecalciferol, at a dose necessary to overcome the deficiency.

Vitamin D overdose causes physical and mental incapacity and intrinsic heart and eye conditions, due to hypercalcaemia, when managed amid pregnancy.  

 Nursing mothers

 Cholecalciferol and its metabolites are excreted in breast deplete. Caution is required with tall dosages to anticipate the potential risk of hypercalcemia in newborn children. Serum calcium monitoring is advised.

 Pediatrics

 Cholecalciferol capsules should not be given to infants and children under the age of 12 years

 Renal Impairment

 Dose adjustment is not require in patient with renal disability. Cholecalciferol ought to be utilized with caution in patients with impedance of renal work due to the potential worsening related to hypercalcemic impacts amid helpful utilize. Cholecalciferol must not be used in severe renal impairment metabolic as conversion to the active metabolite calcitriol is impaired and higher doses are generally required in an.

 Hepatic Impairment

 No dosage adjustment is needed. For details see 

WARNINGS AND PRECAUTIONS:

 OVER DOSAGE

 Symptoms

 Acute or chronic overdose of Cholecalciferol can cause hypercalcaemia, an increase in the serum and urinary concentrations of calcium. The indications of hypercalcaemia are not exceptionally particular and comprise of sickness, spewing, the runs frequently within the early stages and afterward obstruction, anorexia, weakness, migraine, muscle and joint torment, muscle shortcoming. polydipsia, polyuria arrangement of renal calculi, nephrocalcinosis, kidney disappointment, and calcification of delicate tissues, changes in ECG estimations, arrhythmias and pancreati- tis. In exceptional and kept cases there are reports that hypercalcaemia is deadly. 

 Treatment of overdose

 A normalization of hypercalcaemia due to vitamin D inebriation endures a few weeks. The proposal for the treatment of hypercalcaemia is the evasion of any assist organization of vitamin D, counting supplements, dietary immaterial and the evasion of daylight. A low value calcium or calcium free diet also considered. Rehydration and the treatment with diuretics e.g. furosemide to ensure adequate diuresis should be considered. Extra treatment with calcitonin or corticosteroids can too be considered.

 Phosphate infusions should not be administered to lower hypercalcaemia of hypervita- minosis D because of the dangers of metastatic calcification.

 PRESENTATION

 • Opt-D (Cholecalciferol) 25,000IU: Pack of 4 Oral Soft Gel Capsules

• Opt-D (Cholecalciferol) 100,000IU: Pack of 2 Oral Soft Gel Capsules

• Opt-D (Cholecalciferol) 200,000IU: Pack of 1 Oral Soft Gel Capsule