Description

Konakion MM 10 mg (Vitamin K1) Solution

Composition

• Active ingredient: Phytomenadione (Vitamin K1) – 10 mg per 1 ml ampoule.
• Excipients: glycocholic acid, lecithin, sodium hydroxide, hydrochloric acid, water for injections.

Description

Konakion MM 10 mg is a clear, sterile yellow-brown solution for oral or intramuscular administration. It contains a micellar solution of fat-soluble vitamin K1 designed for enhanced absorption, even in patients with impaired bile production or fat malabsorption. Manufactured by Roche Pharmaceuticals, Konakion MM is typically supplied in 1 ml glass ampoules.

Pharmacological Action

Phytomenadione (vitamin K1) is a vital cofactor for hepatic synthesis of coagulation factors II, VII, IX, and X, as well as proteins C and S. Without adequate vitamin K1, the gamma-carboxylation of glutamic acid residues in these proteins is impaired, leading to dysfunctional clotting and increased bleeding risk. Konakion MM rapidly restores physiological levels of active vitamin K1, reactivating coagulation pathways and reducing haemorrhagic complications.

Indications

Konakion MM 10 mg is indicated for:

• Prevention and treatment of vitamin K deficiency bleeding (VKDB) in neonates and infants.
• Vitamin K deficiency due to chronic liver disease, biliary obstruction, or intestinal malabsorption.
• Hypoprothrombinaemia induced by long-term antibiotic therapy.
• Antidote to overdosage or prolonged treatment with coumarin anticoagulants (e.g., warfarin).

Dosage and Administration

• **Neonates and infants**: 1–2 mg orally or intramuscularly as prophylaxis at birth or treatment in case of bleeding.
• **Adults**: 10 mg intramuscularly or orally; repeat dose as required per clinical status.
• **Warfarin reversal**: In non-urgent cases, 2.5–5 mg orally. In urgent reversal, IV route preferred under clinical supervision.
• Route of administration: Oral, intramuscular, or intravenous (off-label/emergency, with risk of anaphylaxis).

Always follow physician’s instructions. Do not self-administer intramuscular or IV injections without clinical supervision.

Contraindications

• Known hypersensitivity to phytomenadione or formulation excipients.
• Severe hepatic failure with no capacity for clotting factor synthesis.
• IV administration contraindicated unless medically justified due to rare risk of anaphylactic shock.

Side Effects

• Common: facial flushing, sweating, dizziness, taste disturbances (oral route).
• Less common: injection site pain or hematoma (IM route), mild elevation of liver enzymes.
• Rare: hypersensitivity reactions, bronchospasm, anaphylaxis (especially IV route).
• Neonates: risk of hemolysis or hyperbilirubinemia in high doses.

Precautions

• Use with caution in patients with liver disease or coagulopathies.
• Do not mix Konakion MM with other IV fluids in the same syringe or line.
• Carefully monitor INR when co-administered with anticoagulants.

Interactions

• Antagonizes the effects of vitamin K antagonists (e.g., warfarin, acenocoumarol).
• Broad-spectrum antibiotics may increase vitamin K deficiency by disrupting gut flora.
• Bile acid sequestrants (e.g., cholestyramine) reduce vitamin K absorption.
• Mineral oils, orlistat, and certain laxatives may impair absorption of fat-soluble vitamins.

Overdose and Management

Toxicity is rare due to high therapeutic index. Overdose symptoms are uncommon but may include transient flushing, hyperbilirubinemia in neonates, or hemolysis in G6PD-deficient infants. Treatment is symptomatic and supportive.

Use in Pregnancy and Lactation

Vitamin K1 does not cross the placenta efficiently; neonatal prophylaxis is essential. Konakion MM is considered safe in pregnancy at therapeutic doses. It may be used in breastfeeding women—vitamin K1 is excreted in low amounts into breast milk.

Use in Pediatrics

Neonatal prophylaxis with Konakion MM significantly reduces early and late vitamin K deficiency bleeding (VKDB). Intramuscular administration offers sustained protection, whereas oral prophylaxis may require multiple doses.

WHO Bulletin on VKDB prophylaxis

Storage

• Store in original packaging at 15–25 °C.
• Protect from light and moisture.
• Do not freeze. Keep ampoules tightly sealed until use.
• Discard after expiration date.

Clinical Studies and Evidence

A systematic review of vitamin K prophylaxis strategies showed intramuscular Konakion MM at birth prevented >95% of late VKDB compared to oral routes (Cornelissen et al., 2017). Cochrane Review

In adults on warfarin with elevated INR, low-dose oral vitamin K1 (1–2.5 mg) normalized coagulation faster than placebo without excessive clotting risk. Crowther et al., NEJM

Summary

Konakion MM 10 mg is a clinically validated formulation of vitamin K1 indicated for the prevention and treatment of deficiency states and coagulopathy. With multiple administration routes and well-established efficacy, it is considered essential for neonatal prophylaxis and adult reversal of anticoagulation. Use must be guided by medical professionals, particularly in populations at risk for liver dysfunction or bleeding disorders.