International reference: 4 US FDA recalls for this ingredient

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. (neutral)

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. (neutral)

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. (neutral)

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. (neutral)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Rwanda.

Registered Rwanda · Rwanda FDA

WOSULIN -N-100 IU/ML

Neutral Insulin Injection 100 IU/ml

Rwanda FDA-HBP-MA-0136 Injection 100 IU/ml alimentary tract and metabolism

What it does

Insulin is a hormone used to control blood sugar levels in people with diabetes.

Commonly used for: diabetes (diabetes mellitus)

Read more in plain English ↓

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

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
Rwanda FDA-HBP-MA-0136
Registration date
17/08/2024
Expiry date
16/08/2029
Status
Registered
Active ingredient
Neutral Insulin Injection 100 IU/ml
Dosage form
Injection
Strength
100 IU/ml
Pack size
10ml Vial
Therapeutic class
-
ATC class (WHO)
A10AB - Insulins and analogues for injection, fast-acting
RxNorm RxCUI
253182
Manufacturer / MAH
Wockhardt
Applicant / LTR
Wockhardt Limited,
Country of origin
INDIA
Manufacturer location
87A, Bhimpore, Bhimpore, Nani Daman, Dadra and Nagar Haveli and Daman and Diu 396210, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:05 · updated 2026-09-21 02:30:19

Drug Interactions

4
Check interactions

Pharmacodynamic Warnings

Insulin appears in TABLE 14: Antidiabetic drugs

Moderate (1)

Insulin - increases risk of hypoglycaemia

Metreleptin is predicted to increase the risk of hypoglycaemia when given with insulin. Monitor blood glucose and adjust dose.

Moderate Theoretical

Unknown (3)

Insulin - increases risk of hypoglycaemia

Fibrates are predicted to increase the risk of hypoglycaemia when given with insulin.

Unknown Theoretical

Insulin - increases risk of severe hypoglycaemia

Macrolides (clarithromycin) might increase the risk of severe hypoglycaemia when given with insulin.

Unknown Theoretical

Insulin - increases risk of severe hypoglycaemia

Clarithromycin might increase the risk of severe hypoglycaemia when given with insulin.

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About insulin

Insulin is a hormone used to control blood sugar levels in people with diabetes.

What it treats

  • diabetes (diabetes mellitus)

How it works

Insulin helps lower blood sugar by allowing sugar to enter the body's cells for energy.

Who it's for

This medication is for individuals with diabetes who need help managing their blood sugar levels.

Cautions

  • • Use with care if you are taking other diabetes medications.

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

About neutral

This medication is used to treat various health conditions. Please consult your healthcare provider for specific information.

How it works

The exact mechanism of action for this medication is not specified.

Who it's for

This medication is suitable for patients with certain health conditions as determined by a healthcare provider.

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

Clinical monograph: Insulin

BNF-referenced

Insulin is a peptide hormone produced by the beta cells of the pancreas that plays a crucial role in glucose metabolism. It facilitates the uptake of glucose into tissues, particularly muscle and adipose tissue, and inhibits hepatic glucose production. Insulin is used primarily in the management of diabetes mellitus, effectively lowering blood glucose levels and preventing hyperglycemia.

Indications

  • Diabetes mellitus (type 1 and type 2)
  • Diabetic ketoacidosis
  • Hyperglycemia due to other conditions
  • Management of blood glucose levels during surgery
  • Continuous subcutaneous insulin infusion therapy

Dosage

Children: For children aged 1-17 years, insulin is administered immediately before meals or when necessary shortly after meals, according to individual requirements. Specific dosing should be determined based on blood glucose monitoring and should be referred to the BNF for Children for precise guidance.

Adults: The dosage of insulin varies based on individual needs and is typically guided by blood glucose monitoring. It is recommended to consult local protocols for specific dosing instructions.

Mechanism of action

Insulin has a direct inhibitory effect on lipase, which is involved in the mobilization of fatty acids. In the absence of insulin, there is an abnormally high rate of conversion of protein to glucose, primarily in the liver. Insulin stimulates glycogen synthesis and enhances facilitated diffusion of glucose and the active transport of amino acids, although the exact mechanisms for these actions are not fully understood.

Pharmacodynamics

Insulin's primary pharmacodynamic effect is the reduction of blood glucose levels. It promotes the uptake of glucose by cells, increases glycogen synthesis in the liver, and inhibits gluconeogenesis. Insulin also influences lipid metabolism by inhibiting lipolysis and encouraging fat storage. Additionally, insulin enhances protein synthesis by promoting amino acid uptake into cells.

Pharmacokinetics

Insulin is administered by injection and is rapidly absorbed into the bloodstream. Its onset, peak, and duration of action depend on the formulation used (e.g., rapid-acting, short-acting). The half-life of insulin is typically around 5 to 10 minutes, but its effects can last several hours depending on the formulation. It is metabolized primarily in the liver and kidneys.

Contra-indications

  • Hypersensitivity to insulin or any of its excipients
  • Hypoglycemia

Adverse effects

  • Hypoglycemia
  • Injection site reactions
  • Weight gain
  • Allergic reactions
  • Edema
  • Lipodystrophy

Interactions

  • Metreleptin may increase the risk of hypoglycemia when used with insulin
  • Fibrates may increase the risk of hypoglycemia when used with insulin
  • Macrolides may increase the risk of severe hypoglycemia when used with insulin
  • Clarithromycin may increase the risk of severe hypoglycemia when used with insulin

Precautions

  • Monitor blood glucose levels regularly, especially when changing insulin preparations
  • Use caution in patients with renal impairment, as insulin clearance may be reduced
  • Patients should be advised about the risks of hypoglycemia and how to manage it
  • Should be used with caution in patients with cardiovascular disease

Pregnancy

Insulin is generally considered safe for use during pregnancy, but dosages may need to be adjusted.

Breast-feeding

Insulin is compatible with breastfeeding; insulin does not pass into breast milk in significant amounts.

Storage

Store unopened vials or pens in a refrigerator (2-8°C). Once opened, insulin can be stored at room temperature (below 25°C) for up to 28 days, depending on the formulation.

Formulations

  • Insulin human 500 units/ml solution for injection
  • Insulin human 100 units/ml solution for injection
  • Insulin porcine 100 units/ml solution for injection
BNF 85 (British National Formulary) p.813 BNF for Children 2019-2020 p.493 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: neutral

Neutral is not a specific drug name but commonly refers to various compounds that may have a neutral pH or pharmacological properties. In a pharmacological context, 'neutral' often describes substances that do not have significant acidic or basic properties, which can affect their solubility, absorption, and activity in biological systems.

Dosage

Children: Refer to specific drug guidelines.

Adults: Refer to specific drug guidelines.

Mechanism of action

The mechanism of action for neutral compounds can vary widely based on the specific substance in question. Many neutral molecules may act as buffers, stabilisers, or inert carriers in drug formulations, affecting the stability and bioavailability of active pharmaceutical ingredients. The pharmacological effects depend largely on the specific context and interactions with biological systems.

Pharmacodynamics

Pharmacodynamics for neutral substances is typically less pronounced than for active drugs. However, they can influence the overall pharmacological environment, affecting drug solubility and absorption rates. Neutral compounds can also modulate the pharmacokinetics of co-administered active drugs by altering their solubility or distribution in the body.

Pharmacokinetics

The pharmacokinetics of neutral compounds depend on their specific chemical nature. Generally, neutral substances are absorbed in the gastrointestinal tract based on their solubility. Distribution, metabolism, and excretion will also depend on the specific characteristics of the substance. However, in pharmaceutical formulations, neutral excipients often aid in the stability and delivery of active ingredients rather than contributing significantly to the pharmacokinetics themselves.

Pregnancy

Consult a healthcare provider to evaluate the risk-benefit ratio as data may be limited.

Breast-feeding

Consult a healthcare provider to determine safety as limited data may be available.

Storage

Store in a cool, dry place, away from direct sunlight and moisture.

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: Insulin

PubChem CID 70678557

Molecular formula: C256H381N65O77S6

Mechanism of action

INSULIN HAS DIRECT INHIBITORY EFFECT ON LIPASE CONCERNED WITH MOBILIZATION OF FATTY ACIDS, WHILE GROWTH HORMONE, GLUCOCORTICOIDS, THYROID HORMONES & CATECHOLAMINES ENHANCE LIPOLYSIS. IN ABSENCE OF INSULIN THERE IS ABNORMALLY HIGH RATE OF CONVERSION OF PROTEIN TO GLUCOSE. ... PROTEINS & AMINO ACIDS ARE CONVERTED TO GLUCOSE @ ABNORMALLY HIGH RATE IN INSULIN DEFICIENCY. THE LIVER IS SITE OF CONVERSION. PROTEIN & AMINO ACIDS ARE MOBILIZED FROM PERIPHERAL TISSUES. INSULIN ACTS TO.../STIMULATE/ GLYCOGEN SYNTHESIS. MECHANISM OF IMPORTANT ACTIONS OF INSULIN TO ENHANCE FACILITATED DIFFUSION OF GLUCOSE & ACTIVE TRANSPORT OF AMINO ACIDS ARE NOT KNOWN.

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.