Registered Tanzania · TMDA

CILATIN 50

Cisplatin 1 mg/ml,Hydrochloric acid Q.S ml,Sodium Chloride 9.0 mg/6 mL,Sodium Hydroxide QS mg/6 mL,Water for Injection QS ml

TAN 25 HM 0433 Injection 50 antineoplastic and immunomodulating agents INN generic

What it does

Cisplatin is a chemotherapy medication used to treat various types of cancer.

Commonly used for: cancer (various types, including testicular and ovarian cancer), bladder cancer, lung cancer

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
TAN 25 HM 0433
Registration date
2025-08-14
Expiry date
2030-08-13
Status
Registered/Compliant
Active ingredient
Cisplatin 1 mg/ml,Hydrochloric acid Q.S ml,Sodium Chloride 9.0 mg/6 mL,Sodium Hydroxide QS mg/6 mL,Water for Injection QS ml
Dosage form
Injection
Strength
50
Pack size
-
Therapeutic class
-
ATC class (WHO)
L01XA - Platinum compounds
RxNorm RxCUI
2555
Manufacturer / MAH
Hetero Labs
Applicant / LTR
Hetero Labs Limited
Country of origin
INDIA
Manufacturer location
Polepally, Telangana 509302, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:44:40 · updated 2026-10-19 03:00:45

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About cisplatin

Cisplatin is a chemotherapy medication used to treat various types of cancer.

What it treats

  • cancer (various types, including testicular and ovarian cancer)
  • bladder cancer
  • lung cancer

How it works

Cisplatin works by interfering with the DNA in cancer cells, preventing them from growing and dividing.

Who it's for

Cisplatin is for patients diagnosed with certain types of cancer.

Cautions

  • • Be careful if you are taking other medications that may harm the kidneys.
  • • Avoid medications that can cause nerve damage.
  • • Use with caution if taking drugs that affect blood cell production.
  • • Watch out for drugs that can harm hearing.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About hydrochloric

Hydrochloric acid is a substance that helps with digestion in the stomach.

What it treats

  • stomach acidity issues
  • digestive problems

How it works

It aids in breaking down food and absorbing nutrients in the stomach.

Who it's for

It is used for people who have low stomach acid or certain digestive disorders.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About hydroxide

Hydroxide is a compound used to help neutralize stomach acid and relieve indigestion or heartburn.

What it treats

  • indigestion
  • heartburn

How it works

Hydroxide works by neutralizing the excess acid in the stomach, which helps to reduce discomfort.

Who it's for

Hydroxide is suitable for adults and children experiencing symptoms of excess stomach acid.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Cisplatin

BNF-referenced

Cisplatin is a chemotherapy medication used primarily to treat various types of cancer, including testicular, ovarian, bladder, lung, cervical, and head and neck cancers. It is classified as a platinum-based antineoplastic agent and functions by interfering with the DNA replication of rapidly dividing cancer cells, ultimately leading to apoptosis.

Indications

  • Advanced ovarian cancer
  • Small cell lung cancer
  • High-risk seminoma (stage I) testicular germ cell tumors (adjuvant treatment)
  • Bladder cancer
  • Cervical cancer
  • Head and neck cancer

Dosage

Children: Paediatric dosing should be determined based on specific clinical guidelines and product literature, as this information is not directly provided in the BNF.

Adults: The dosage for adults varies based on the specific type of cancer being treated and should be determined by consulting product literature. Typically, it is administered by intravenous infusion.

Mechanism of action

Cisplatin exerts its anticancer effects primarily through the formation of DNA cross-links. The drug binds to DNA, forming interstrand and intrastrand cross-links that inhibit DNA replication and transcription, triggering cellular apoptosis. This mechanism is facilitated by the activation of cellular signaling pathways that respond to DNA damage, leading to cell cycle arrest and subsequent cell death.

Pharmacodynamics

Cisplatin is a cytotoxic agent that targets the DNA of cancer cells, causing significant damage that disrupts the normal processes of cell division and function. It is particularly effective against rapidly proliferating tumors. The drug's efficacy is influenced by factors such as the tumor type, stage, and cellular repair mechanisms.

Pharmacokinetics

Cisplatin has a variable pharmacokinetic profile, with a distribution half-life of approximately 30 minutes and a terminal half-life of about 48 to 100 hours. It is primarily eliminated through the kidneys, and renal function significantly affects its clearance. The drug is known to have dose-dependent nephrotoxicity, necessitating careful monitoring of renal function during treatment.

Contra-indications

  • Hypersensitivity to cisplatin or any of its components
  • Severe renal impairment
  • Myelosuppression
  • Pregnancy

Adverse effects

  • Nausea
  • Vomiting
  • Alopecia
  • Nephrotoxicity
  • Ototoxicity
  • Leukopenia
  • Thrombocytopenia
  • Anaphylactoid reactions
  • Cardiac arrest (rare)
  • Acute leukemia (rare)

Interactions

  • Other nephrotoxic drugs (e.g., aminoglycosides, NSAIDs)
  • Ototoxic agents (e.g., loop diuretics)
  • Anticonvulsants (may require dosage adjustments)
  • Radiation therapy (increased risk of toxicity)

Precautions

  • Careful monitoring of renal function
  • Hydration before and after administration to reduce nephrotoxicity
  • Monitoring for signs of ototoxicity
  • Caution in patients with pre-existing hearing impairment
  • Use with caution in patients with cardiovascular disorders

Pregnancy

Cisplatin is classified as a Category D drug. It is contraindicated in pregnancy due to potential harm to the fetus.

Breast-feeding

Cisplatin is not recommended during breastfeeding due to potential excretion in breast milk and risk to the infant.

Storage

Store in a cool, dry place away from light. Store the solution in the refrigerator and protect from light.

Formulations

  • Cisplatin 1 mg/ml solution for infusion
  • Cisplatin 50 mg/50 ml solution for infusion
BNF 85 (British National Formulary) p.1030 BNF for Children 2019-2020 p.590 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: hydrochloric

Hydrochloric acid, commonly known as stomach acid, is a clear, colorless solution that is produced in the stomach. It plays a critical role in digestion by creating an acidic environment that aids in the breakdown of food and activates digestive enzymes. In a pharmaceutical context, hydrochloric acid is used in various formulations to adjust pH levels, facilitate drug absorption, and as a component in sterile preparations.

Indications

  • Adjustment of pH in pharmaceutical formulations
  • Facilitation of drug absorption
  • Used in sterile preparations

Dosage

Children: Refer to specific product guidelines for dosing information, as hydrochloric acid is typically used in a controlled setting based on formulation requirements.

Adults: Refer to specific product guidelines for dosing information, as hydrochloric acid is typically used in a controlled setting based on formulation requirements.

Mechanism of action

Hydrochloric acid dissociates in aqueous solution to release hydrogen ions (H+), leading to a decrease in pH. This acidic environment promotes the activation of pepsinogen to pepsin, an enzyme essential for protein digestion. Additionally, the acidity aids in the absorption of certain minerals and drugs that require an acidic environment for optimal bioavailability.

Pharmacodynamics

The primary pharmacodynamic action of hydrochloric acid is the maintenance of gastric acidity, which is essential for normal digestive processes. The acidic environment helps in denaturing proteins, activating digestive enzymes, and providing a barrier against pathogenic microorganisms. Its effects can influence the absorption and efficacy of various medications, particularly those that are pH-dependent.

Pharmacokinetics

Hydrochloric acid does not undergo significant systemic absorption when used in its normal contexts, as it acts locally within the gastrointestinal tract. The amount of hydrochloric acid produced by the stomach varies with food intake and physiological needs. It is secreted by parietal cells in the gastric mucosa, and its secretion is regulated by neural, hormonal, and local factors. The half-life of hydrochloric acid is not applicable as it is continuously produced and neutralized within the gastrointestinal tract.

Contra-indications

  • Hypersensitivity to hydrochloric acid or any of its components
  • Severe renal impairment
  • Active gastrointestinal bleeding

Adverse effects

  • Abdominal pain
  • Diarrhea
  • Nausea
  • Vomiting
  • Esophageal irritation
  • Gastric mucosal irritation
  • Electrolyte imbalances

Interactions

  • May interact with alkaline substances, potentially neutralizing hydrochloric acid
  • Caution with antacids as they may affect the efficacy of hydrochloric acid

Precautions

  • Use with caution in patients with a history of gastritis or gastric ulcers
  • Monitor electrolytes in prolonged use
  • Use cautiously in patients with respiratory conditions due to potential aspiration risks

Pregnancy

Hydrochloric acid is classified as a category C drug. Use during pregnancy only if clearly needed and the potential benefits justify the risks to the fetus.

Breast-feeding

There is limited data on the excretion of hydrochloric acid in human milk. Use with caution during breastfeeding.

Storage

Store in a cool, dry place away from direct sunlight and heat. Ensure the container is tightly closed.

Formulations

  • Oral solutions
  • Injectable forms
  • Tablets

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: hydroxide

BNF-referenced

Hydroxide, represented by the molecular formula HO-, is an anion commonly found in various chemical and biological systems. It plays a crucial role in acid-base chemistry and is a fundamental component in many biochemical pathways. Hydroxide ions are involved in maintaining pH balance in biological systems and participate in various metabolic processes.

Dosage

Children: Refer to specific guidelines for pediatric dosing; consult the BNF for Children for accurate dosage information.

Adults: Refer to specific guidelines for use; dosage may vary based on the context of use.

Mechanism of action

Hydroxide ions act primarily as bases, neutralizing acids to form water and salts. They participate in various biochemical pathways, including selenium metabolism and the degradation of reactive oxygen species. Hydroxide can influence enzyme activity and stability by altering the pH of the environment, thereby affecting metabolic reactions.

Pharmacodynamics

Hydroxide ions can impact biological processes by changing the local pH, which influences enzyme activity, ion transport, and the solubility of other compounds. Their ability to neutralize acids can help regulate physiological pH, contributing to homeostasis in living organisms.

Pharmacokinetics

As an inorganic ion, hydroxide does not undergo traditional pharmacokinetic processes like absorption, distribution, metabolism, or excretion. Instead, it is rapidly equilibrated in biological fluids and participates in acid-base reactions, having immediate effects on the local environment.

Pregnancy

There is limited information regarding the use of hydroxide during pregnancy. Consult a healthcare professional for advice.

Breast-feeding

Limited data is available on the excretion of hydroxide in breast milk. Consult a healthcare professional before use.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Cisplatin

PubChem CID 5702198

Molecular formula: Cl2H6N2Pt

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.