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Generic Samsca Information
Introduction
Samsca (generic name: Tolvaptan) is a selective vasopressin V₂‑receptor antagonist approved for the management of specific cardiovascular‑related disorders. It belongs to the cardiovascular therapeutic group and is manufactured by Otsuka Pharmaceutical Co., Ltd. In Hong Kong, Samsca is prescribed for patients with autosomal dominant polycystic kidney disease (ADPKD) and for the treatment of clinically significant hyponatraemia caused by the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Its targeted mechanism helps control water balance, slowing disease progression and correcting low serum sodium levels.
What is Samsca?
Samsca is a tablet formulation that contains the active compound Tolvaptan, a small‑molecule antagonist of the vasopressin V₂ receptor. The drug was developed by Otsuka and received regulatory approval in the United States (FDA, 2012) and the European Union (EMA, 2015) for ADPKD, and later for hyponatraemia associated with SIADH. In Hong Kong, the Medicines and Poisons Ordinance (Cap. 138) classifies Samsca as a prescription‑only medicine, reflecting its need for professional monitoring.
- Brand name: Samsca®
- Generic name: Tolvaptan
- Manufacturer: Otsuka Pharmaceutical Co., Ltd.
How Samsca Works
Tolvaptan blocks the binding of arginine vasopressin (AVP) to the V₂ receptors located on the basolateral membrane of renal collecting‑duct cells. Under normal physiology, AVP activation of V₂ receptors triggers the insertion of aquaporin‑2 water channels into the apical membrane, promoting water reabsorption and concentrating urine. By inhibiting this pathway, Samsca reduces the renal tubular reabsorption of free water, leading to an aquaresis (water excretion without loss of electrolytes).
- Onset: Increased urine output is typically observed within 2‑4 hours after the first dose.
- Duration: The aquaretic effect persists for approximately 12 hours, matching the drug’s half‑life of 12 hours in healthy adults.
- Clearance: Tolvaptan is metabolised primarily by hepatic CYP3A4/5 enzymes; renal excretion is minimal.
In ADPKD, the drug’s ability to lower intracellular cyclic AMP (cAMP) levels in cyst‑lining epithelial cells reduces cyst growth, thereby slowing the decline in glomerular filtration rate (GFR). In SIADH, the aquaresis corrects dilutional hyponatraemia by allowing excess water to be eliminated while preserving sodium.
Conditions Treated with Samsca
-
Autosomnal Dominant Polycystic Kidney Disease (ADPKD)
ADPKD affects roughly 1 in 400–1,000 individuals worldwide, with an estimated prevalence of .1 % in Hong Kong’s adult population. Progressive cyst formation leads to a steady loss of renal function. Clinical trials (e.g., TEMPO 3:4) demonstrated that Tolvaptan reduces the rate of total kidney volume increase and delays the need for renal replacement therapy. -
Hyponatraemia secondary to SIADH
SIADH is a common cause of euvolemic hyponatraemia, especially in patients with malignancies, pulmonary disease, or central nervous system disorders. In Hong Kong hospitals, SIADH accounts for approximately 10 % of inpatient hyponatraemia cases. Tolvaptan’s aquaretic action raises serum sodium concentrations safely when fluid restriction alone is insufficient.
Both indications require careful monitoring of serum sodium and liver function, as described in the prescribing information.
Who is Samsca For?
- Patients with confirmed ADPKD who have an estimated GFR between 25–75 mL/min/1.73 m² and demonstrate rapid disease progression (e.g., increasing total kidney volume).
- Adults with symptomatic SIADH whose serum sodium is ≤ 125 mmol/L despite fluid restriction, and who are at risk of neurologic complications.
- Individuals who can undergo regular laboratory monitoring, including liver enzymes (ALT, AST), serum sodium, and renal function, because Tolvaptan carries a risk of hepatotoxicity and rapid changes in electrolytes.
- Patients without severe hepatic impairment, as severe liver disease (Child‑Pugh C) is a contraindication.
Contra‑indications include pregnancy, breastfeeding, known hypersensitivity to Tolvaptan, uncontrolled hypernatraemia, and concomitant use of strong CYP3A4 inducers (e.g., rifampicin) that could markedly reduce drug exposure.
Risks, Side Effects, and Interactions
Common
- Thirst – reported in > 30 % of users; usually mild and transient.
- Polyuria / Increased urinary frequency – a direct consequence of aquaresis.
- Elevated liver enzymes – ALT or AST elevations observed in up to 4 % of patients; requires periodic monitoring.
Rare
- Hypernatraemia – excessive water loss may raise serum sodium > 150 mmol/L; monitor especially after dose escalation.
- Hypotension – due to intravascular volume contraction; patients on antihypertensives may need dose adjustments.
Serious
- Drug‑induced liver injury – rare but potentially fatal; cases have required discontinuation and, in extreme scenarios, liver transplantation. Immediate cessation is advised if ALT or AST exceeds 3 × ULN with concomitant bilirubin rise.
- Severe dehydration – can precipitate acute kidney injury; patients must maintain adequate fluid intake balanced against aquaresis.
Clinically Relevant Drug–Drug Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) increase Tolvaptan plasma concentration; dose reduction or avoidance is recommended.
- CYP3A4 inducers (e.g., carbamazepine, phenytoin, St. John’s wort) decrease exposure, potentially reducing efficacy.
- Concomitant lithium – Tolvaptan may increase lithium serum levels, heightening the risk of toxicity; close monitoring is essential.
- Diuretics – additive aquaretic effect may lead to excessive volume depletion; adjust diuretic dose as clinically indicated.
Patients should disclose all medications, including over‑the‑counter products and herbal supplements, to their healthcare provider before initiating Samsca.
Practical Use: Dosing, Missed Dose, Overdose
- Starting dose (ADPKD) – 45 mg orally once daily in the morning for the first 3 days, then titrated to 60 mg twice daily (morning and afternoon) if tolerated.
- Hyponatraemia (SIADH) – 15 mg orally once daily, with possible increase to 30 mg once daily based on serum sodium response.
Missed dose: If a dose is missed and the next scheduled dose is > 12 hours away, take the missed tablet as soon as remembered. If the interval to the next dose is < 12 hours, skip the missed dose and resume the regular schedule. Do not double‑dose.
Overdose: Symptoms may include profound polyuria, dehydration, and rapid increase in serum sodium. In suspected overdose, seek emergency medical care; treatment is supportive with intravenous fluids and careful electrolyte monitoring.
Food & Alcohol: Samsca can be taken with or without food. Alcohol may exacerbate dehydration; limit intake while on therapy.
Comorbidities: Patients with chronic liver disease, heart failure, or uncontrolled hypertension require individualized dosing and more frequent laboratory assessments.
Buying Samsca from Our Online Pharmacy
Samsca is available for purchase through our online pharmacy in Hong Kong, offering a discreet, cost‑effective pathway for patients who face limited access or high out‑of‑pocket expenses.
- Affordable pricing: We source the medication near manufacturer cost, passing savings directly to the consumer.
- Verified quality: All batches are obtained from licensed overseas pharmacies that meet Good Manufacturing Practice (GMP) standards; authenticity is confirmed by serial‑number verification.
- Guaranteed delivery: Options include express shipping (7 days ≈ HK delivery) or regular airmail (approximately 3 weeks). Packages are sealed, labelled only with the patient’s name, and shipped in discreet packaging to protect privacy.
- Pharmacy broker service: We act as a brokerage, linking patients with reputable international suppliers while complying with Hong Kong import regulations for personal use. This model enables access to international formulations that may not be stocked locally, without compromising safety.
Our platform adheres to the highest data‑protection standards, ensuring that personal health information remains confidential throughout the ordering process.
FAQ
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Is Samsca approved for any indication besides ADPKD and SIADH?
No, regulatory agencies in Hong Kong, the United States, and the European Union have approved Tolvaptan only for autosomal dominant polycystic kidney disease and for hyponatraemia secondary to the syndrome of inappropriate antidiuretic hormone secretion. Off‑label uses are not endorsed without specialist supervision. -
Can Samsca be stored in a refrigerator?
Samsca tablets are stable at room temperature (15 °C–30 °C). Refrigeration is not required and may cause condensation that could affect tablet integrity. Store the medication in a dry place, away from direct sunlight and moisture. -
What does the tablet look like and how can I identify it?
The commercial tablets are white, film‑coated, and oval‑shaped. The strength is indicated on one side (e.g., “45 mg” or “60 mg”). Imprint markings vary by manufacturer; typical codes include “OTCZ‑45” for 45 mg tablets. -
Are there any regional formulation differences between the US and Asian markets?
The active ingredient, Tolvaptan, is identical across regions. However, inactive excipients such as lactose, maize starch, or magnesium stearate may differ slightly to meet local regulatory requirements. These variations rarely affect clinical efficacy but may be relevant for patients with specific excipient allergies. -
How does personal import of Samsca into Hong Kong work legally?
Hong Kong permits individuals to import a 3‑month supply of prescription medication for personal use, provided they possess a valid prescription from a Hong Kong‑licensed practitioner. Our online pharmacy supplies the required documentation to facilitate customs clearance under the Personal Importation Scheme. -
Will taking Samsca affect drug testing for employment or sports?
Tolvaptan is not listed on standard occupational or anti‑doping screening panels. Nonetheless, if a specific test includes a broad metabolite screen, it may be detected. Patients should disclose all medications to testing authorities if required. -
Can I travel with Samsca on an international flight?
Yes, but keep tablets in their original packaging with a copy of the prescription and the pharmacy receipt. Carry them in hand luggage to avoid temperature extremes in cargo holds, and be prepared to present documentation to customs or airline security if asked. -
What is the historical background of Tolvaptan development?
Tolvaptan was discovered in the early 199s by Otsuka researchers aiming to create selective vasopressin receptor antagonists. After preclinical success, Phase III trials demonstrated its efficacy in ADPKD (TEMPO 3:4) and SIADH, leading to FDA approval in 2012. Ongoing studies continue to evaluate long‑term renal outcomes. -
How does Tolvaptan compare with older diuretic therapies for hyponatraemia?
Traditional loop or thiazide diuretics promote natriuresis (loss of sodium) and water, risking further sodium depletion. Tolvaptan uniquely promotes free‑water excretion without significant sodium loss (aquaresis), allowing a more precise correction of serum sodium while preserving electrolytes. -
Is there any evidence that Tolvaptan improves quality of life in ADPKD patients?
Patient‑reported outcomes from the TEMPO 3:4 extension study indicated modest improvements in physical functioning scores and reduced pain related to kidney enlargement. However, benefits are primarily disease‑modifying rather than symptomatic, and individual experiences may vary. -
What should I do if I experience sudden severe thirst while on Samsca?
Intense thirst is a common side effect reflecting increased free‑water loss. Sip water gradually to maintain hydration, but avoid large boluses that could negate the drug’s effect. If thirst becomes unmanageable or is accompanied by dizziness, contact a healthcare professional for possible dose adjustment.
Glossary
- Vasopressin V₂ receptor
- A protein located on kidney collecting‑duct cells that mediates water reabsorption when activated by the hormone arginine vasopressin.
- Aquaresis
- The excretion of free water without accompanying loss of electrolytes, leading to an increase in urine volume and a rise in serum sodium concentration.
- cAMP (cyclic adenosine monophosphate)
- An intracellular messenger that promotes cyst growth in ADPKD; Tolvaptan lowers cAMP levels, thereby slowing disease progression.
- Hepatotoxicity
- Liver injury caused by a medication, manifested by elevated liver enzymes or, in severe cases, liver failure.
⚠️ Disclaimer
The information provided about Samsca is for general knowledge only. It does not replace professional medical consultation. All treatment decisions should be made under the supervision of a qualified healthcare provider. We assume all readers are responsible adults capable of making informed decisions about their health. Our online pharmacy offers access to Samsca for individuals who may have limited availability through traditional pharmacies, prescription‑based insurance schemes, or who are seeking affordable generic alternatives. Always consult your doctor before starting, changing, or discontinuing any medication.
Information about ordering Generic Samsca in online pharmacy asia
Please note that this medicine is a generic version of Samsca.One can buy Generic Samsca online by accepting the following conditions:
- Buyer is above or equal 18 years old;
- Buyer does't have any contraindications to tolvaptan and fully familiar with medication Samsca;
- No paper instructions about side effect warnings or usage directions are sent with Generic Samsca medication. They are available online on our website for information purposes only;
- Ordered medication will be shipped in anonymous discreet package without disclosing its content;
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