LANTUS SOLOSTAR 100/UNITS/ML 5×3ML/PENFILL @

Indications

Approved Uses

To improve glycemic control in adults and pediatric patients ≥6 years with type 1 diabetes mellitus, and in adults with type 2 diabetes mellitus.

Dosage & Administration

Dosing by Condition

Type 1 DM (≥6 years): use as basal insulin once daily as part of a basal-bolus regimen; basal typically ~1/3 to 1/2 of total daily insulin requirement, then titrate to fasting targets. Type 2 DM (adults): start 10 units once daily or 0.1-0.2 units/kg once daily, then titrate (e.g., by 2 units every 3 days or 1-2 units once/twice weekly) to fasting glucose goal while avoiding hypoglycemia.

Initial Dose

Type 2 DM: 10 IU (or 0.2 IU/kg) subcutaneously once daily at the same time each day. Type 1 DM: Approximately 0.2 IU/kg/day as part of a basal-bolus regimen.

Maintenance Dose

Individualized based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use; titrate to glycemic control goals.

Maximum Dose

No specific maximum dose; individualize and titrate to glycemic targets and clinical response.

Children's Dosage

Safety and effectiveness in pediatric patients under 6 years of age have not been established.

Dose Adjustment Notes

Individualize and titrate based on fasting SMBG/CGM and hypoglycemia; adjust with changes in diet, activity, illness, or interacting drugs, and consider lower requirements in renal/hepatic impairment. When switching from twice-daily NPH to once-daily insulin glargine, start at ~80% of the total daily NPH dose (≈20% reduction) and titrate.

How to Take

Subcutaneous injection only (abdomen, thigh, or upper arm) once daily at the same time each day; rotate injection sites. Do NOT administer IV or IM and do NOT use in an insulin pump. For SoloStar: use a new needle each injection, prime per pen instructions, inject and hold the needle in the skin ~10 seconds, then remove; do not mix or dilute with other insulins/solutions.

How to Prepare

Ready-to-use prefilled pen: visually inspect-solution must be clear, colorless, particle-free. Attach a new needle for each injection. Prime/safety test per manufacturer IFU (commonly 2 units) before each injection to ensure flow. Do not mix or dilute. Use only subcutaneously.

Side Effects

Common Side Effects

Hypoglycemia; injection-site reactions (pain, erythema, pruritus, swelling); lipodystrophy; weight gain; peripheral edema; rash (less common).

Safety & Warnings

Contraindications

Contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine or any excipients.

Warnings & Precautions

Major warnings/precautions: hypoglycemia (most common; monitor and educate), never share pens/needles, SC use only (do not give IV/IM), do not mix/dilute with other insulins/solutions, adjust dose with illness/stress/diet/exercise changes, monitor/avoid hypokalemia, TZD + insulin may cause fluid retention/heart failure, rotate injection sites to prevent lipodystrophy/cutaneous amyloidosis, and prevent medication errors by verifying insulin type/strength.

Age Restriction

Approved for use in adults and pediatric patients ≥6 years (not recommended/approved for children <6 years).

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

Key interactions: (1) Thiazolidinediones (pioglitazone/rosiglitazone) + insulin → fluid retention/heart failure risk; (2) agents that increase hypoglycemia risk (other antidiabetics, ACE inhibitors, salicylates, MAOIs, some antidepressants) and agents that raise glucose (corticosteroids, thiazides/loop diuretics, sympathomimetics, thyroid hormones, some antipsychotics); (3) beta-blockers/clonidine may mask hypoglycemia; alcohol may increase hypoglycemia; octreotide/lanreotide may increase or decrease insulin needs.

Interaction Severity

MAJOR: Thiazolidinediones (pioglitazone/rosiglitazone) with insulin-risk of fluid retention/heart failure. MODERATE: Other glucose-lowering drugs (↑ hypoglycemia), ACE inhibitors/salicylates/MAOIs (may ↑ hypoglycemia), corticosteroids/thiazides/sympathomimetics/atypical antipsychotics (may ↑ glucose), beta-blockers (mask hypoglycemia symptoms). MINOR/variable: Alcohol (can ↑ hypoglycemia and impair awareness; effect may be unpredictable).

Food Interaction

No specific food-timing requirement for glargine itself; counsel consistent carbohydrate intake and caution with alcohol due to increased risk of hypoglycemia.

Special Populations

Pregnancy

Category C: Animal reproduction studies have not shown a fetal risk but there are no controlled studies in pregnant women, or animal reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester.

Breastfeeding

It is unknown whether LANTUS is excreted in human milk. Caution should be exercised when LANTUS is administered to a nursing woman.

Children

Safety and effectiveness in pediatric patients under 6 years of age have not been established.

Elderly

Use with caution; hypoglycemia may be more difficult to recognize and more severe. Start at lower doses, titrate slowly, and monitor blood glucose frequently. Renal function decline in elderly may reduce insulin clearance and increase hypoglycemia risk.

Kidney Impairment

No fixed adjustment; dose may need reduction in renal impairment-monitor glucose closely and individualize.

Liver Impairment

No fixed adjustment; dose may need reduction in hepatic impairment-monitor glucose closely and individualize.

Storage & Patient Advice

Storage Conditions

store in a refrigerator (2°c - 8°c)

Preparation Instructions

Ready-to-use prefilled pen: visually inspect-solution must be clear, colorless, particle-free. Attach a new needle for each injection. Prime/safety test per manufacturer IFU (commonly 2 units) before each injection to ensure flow. Do not mix or dilute. Use only subcutaneously.

Stopping the Medicine

Do not stop or change dose abruptly without medical supervision; interruption/inadequate dosing can cause severe hyperglycemia and diabetic ketoacidosis.

Overdose

Overdose primarily causes hypoglycemia (may be prolonged) and can cause hypokalemia; treat mild/moderate with oral fast-acting carbohydrate, and severe with IV dextrose and/or glucagon, followed by ongoing carbohydrate intake and close monitoring for recurrence.

Patient Counseling

Inject subcutaneously once daily at the same time each day; never IV/IM. Rotate injection sites (abdomen, thigh, upper arm) to reduce lipodystrophy/amyloidosis. Use a new needle each time and never share the pen/needles. Do not mix or dilute insulin glargine with other insulins. Check the solution is clear/colorless and use correct pen technique (prime per IFU). Monitor glucose as directed; recognize and treat hypoglycemia (carry fast-acting carbohydrate) and know when to seek help. Keep follow-up for dose titration; do not stop insulin abruptly without medical advice. Storage: unopened pens refrigerated 2-8°C; in-use pen kept <30°C, protected from heat/light, and discarded after 28 days (per product labeling).

Monitoring Requirements

Monitor blood glucose regularly (SMBG/CGM) and assess for hypoglycemia; check HbA1c about every 3 months until stable then at least twice yearly. Monitor potassium in at-risk patients (e.g., high-dose insulin, renal impairment) and monitor weight/edema and injection sites; renal/hepatic function monitoring is clinically appropriate when impairment is present or suspected.

Pharmacology

Mechanism of Action

Insulin glargine is a long-acting insulin analog that binds insulin receptors to increase peripheral glucose uptake and decrease hepatic glucose output; its prolonged action is due to precipitation in subcutaneous tissue after injection (acidic solution neutralizes), causing slow, continuous absorption.

Onset of Action

Onset is gradual, typically about 1-2 hours after subcutaneous injection.

Duration of Effect

Approximately 24 hours (may be shorter in some patients), with a relatively flat/peakless profile compared with NPH.

Half-Life

A conventional plasma half-life is not clinically meaningful for insulin glargine after subcutaneous injection; its clinical effect is governed by slow, continuous absorption from the subcutaneous depot with a duration of action up to ~24 hours (sometimes longer).

Metabolism

After subcutaneous injection, insulin glargine is proteolytically converted mainly to active metabolite M1 (and to a lesser extent M2) in the subcutaneous tissue and systemically; M1 predominates in circulation.

Product Information

Available Dosage Forms

Injection, solution (insulin glargine U-100) supplied as: prefilled disposable pen (SoloStar), 10 mL vial, and 3 mL cartridge (for compatible reusable pens) depending on market.

Composition per Dose

Each 1 mL: Insulin glargine 100 IU (equivalent to 3.6378 mg); Each 3 mL pen: Insulin glargine 300 IU total. Excipients: zinc chloride, m-cresol, glycerol 85%, polysorbate 20, hydrochloric acid, sodium hydroxide, water for injections

Generic Availability

No; brand insulin glargine (Lantus) has authorized generics but original is reference-listed

OTC Alternatives

No OTC alternative - insulin glargine requires a prescription; no OTC insulin equivalent is available for basal insulin replacement

Diabetes Type

Both

Insulin Type

Long-acting

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.