TRANQIPAM is a prescription tranquilizer used to treat various anxiety-related disorders. Its active ingredient is lorazepam, a medicine from the benzodiazepine class that works by calming the brain and nerves. Lorazepam enhances the activity of a natural brain chemical called GABA (gamma-aminobutyric acid), which has a calming effect.
TRANQIPAM is available in three strengths:
- 0.5 mg
- 1 mg
- 2.5 mg
These tablets are used short-term for anxiety and stress management or longer-term under medical supervision for specific conditions.
2. Scheduling Status
TRANQIPAM is classified as a Schedule 5 (S5) medicine, which means it is a controlled substance and should only be used under medical guidance.
3. Composition of TRANQIPAM Tablets
Each strength of TRANQIPAM contains lorazepam along with specific excipients (inactive ingredients). Here’s a detailed breakdown:
Table 1: TRANQIPAM Tablet Composition
| Strength | Lorazepam (mg) | Excipients | Lactose Content (mg) |
|---|---|---|---|
| 0.5 mg | 0.5 | Lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium | 33.875 |
| 1 mg | 1 | Lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium | 67.50 |
| 2.5 mg | 2.5 | Lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium | 134.475 |
đź’ˇ Note: TRANQIPAM contains lactose and sugar, which may be relevant for patients with diabetes or lactose intolerance.
4. What is TRANQIPAM Used For? (Indications)
TRANQIPAM is prescribed for:
- Anxiety Disorders
- Generalized anxiety
- Panic attacks
- Phobias and social anxiety
- Anxiety Caused by Physical (Organic) Illness
- Example: anxiety related to chronic diseases or terminal illness
- Adjustment Disorders
- Stress and anxiety due to life events or emotional distress
đźš« Not suitable for routine tension or everyday stress unless clearly diagnosed as an anxiety disorder.
5. How Does TRANQIPAM Work? (Pharmacology)
Pharmacodynamic Properties:
- Lorazepam acts on the central nervous system (CNS).
- It enhances the effect of GABA, a calming neurotransmitter.
- This results in reduced anxiety, relaxation, and sedation.
Pharmacokinetic Properties:
| Property | Description |
|---|---|
| Absorption | Rapid oral absorption |
| Peak Levels | Reached ~2 hours after taking |
| Half-life | 12–16 hours |
| Protein Binding | 90% of lorazepam binds to plasma proteins |
| Metabolism | Processed in the liver via glucuronidation (not affected by P450 enzymes) |
| Excretion | 70–75% excreted in urine as inactive glucuronide |
6. Who Should NOT Take TRANQIPAM? (Contraindications)
TRANQIPAM is not suitable for patients who:
- Are allergic to lorazepam or any benzodiazepine
- Have severe CNS depression or are in a coma
- Have acute narrow-angle glaucoma
- Suffer from porphyria (a rare metabolic disorder)
- Are diagnosed with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
7. Warnings and Special Precautions
Important Precautions
| Risk Group | Specific Risk |
|---|---|
| Elderly / Debilitated | Increased risk of over-sedation, falls, confusion |
| Patients with Epilepsy | Risk of seizures during abrupt withdrawal |
| Mental Health Disorders | Avoid in psychotic or severely depressed patients unless anxiety is a primary symptom |
| Addiction-prone individuals | Monitor closely – potential for misuse and dependence |
| Liver/Kidney Impairment | Slower clearance and altered drug effect |
| Breathing Disorders | Risk of respiratory depression |
⚠️ TRANQIPAM may impair thinking, judgment, or motor skills. Avoid driving or operating heavy machinery until its effects are known.
8. Risk of Dependence and Withdrawal
Benzodiazepines like TRANQIPAM can cause physical and psychological dependence. Withdrawal symptoms can occur even at therapeutic doses if stopped suddenly. These symptoms include:
- Anxiety
- Tremors
- Sweating
- Insomnia
- Cramps
- Seizures (rare but serious)
Important: Taper the dose gradually under medical supervision when stopping the medicine.
9. Use in Pregnancy and Breastfeeding
| Situation | Recommendation |
|---|---|
| Pregnancy | Use only if clearly needed. Risk of floppy baby syndrome, respiratory depression, and jaundice in newborns. |
| Labour | Should be avoided due to risk to the newborn. |
| Breastfeeding | Avoid, as lorazepam is excreted in breast milk. Risk of sedation and poor feeding in infants. |
10. Possible Drug Interactions
TRANQIPAM can cause additive CNS depression when taken with:
- Alcohol
- Barbiturates
- Opioids
- Antipsychotics
- Sleep medications
- Certain antidepressants
âť— Always tell your doctor about all medicines, supplements, or herbal products you’re taking.
11. How to Take TRANQIPAM (Dosage and Directions)
Dosage Guidelines
| Patient Group | Recommended Dosage |
|---|---|
| Adults (Typical) | 2–3 mg daily, divided into 2–4 doses |
| Range | 1–6 mg/day |
| Elderly / Debilitated | Start with 1–2 mg/day in divided doses |
| Children <12 years | Safety not established – not recommended |
Important Notes:
- Take exactly as prescribed by your doctor.
- Do not increase the dose without consulting your doctor.
- The need for treatment should be re-evaluated periodically.
12. Possible Side Effects
Like all medicines, this medication may cause side effects, although not everyone gets them.
Common Side Effects:
- Drowsiness
- Tiredness
- Dizziness
- Confusion
- Weakness
Less Common:
- Headache
- Sleep disturbances
- Memory problems (transient amnesia)
- Slurred speech
- Urinary issues
- Skin rashes or itching
- Mood changes
Serious Reactions:
- Respiratory depression (especially at high doses)
- Paradoxical reactions (e.g. aggression, rage)
- Blood abnormalities (rare)
- Liver enzyme changes (rare)
đź“Ś Regular blood tests may be advised during long-term use.
13. Symptoms of Overdose and Emergency Treatment
Signs of Overdose:
- Extreme drowsiness
- Confusion
- Slurred speech
- Loss of coordination
- Low blood pressure
- Slow breathing
- Coma (in severe cases)
What To Do:
- Seek emergency medical help immediately
- Treatment is symptomatic and supportive
There is no specific antidote, so hospital care is often necessary.
14. Tablet Appearance
| Strength | Description |
|---|---|
| 0.5 mg | White, round tablet |
| 1 mg | White to off-white, flat, round tablet with bevelled edges, bisected on one side, marked “C11” |
| 2.5 mg | White to off-white, flat, round tablet with bevelled edges, bisected on one side, marked “C18” |
15. Packaging Information
TRANQIPAM is packaged in various bottle and blister formats depending on the strength:
Bottle Packs
| Strength | Pack Sizes | Container |
|---|---|---|
| 0.5 mg | 100, 250, 500, 1000 tablets | Amber Type III glass bottles with screw-on caps, desiccants, and cotton or silica gel inserts |
| 1 mg | 100 tablets | Amber Type III glass bottle with snap cap or tamper-evident cap |
| 2.5 mg | 100 tablets | Amber Type III glass bottle with screw cap and desiccant |
Blister Packs
- 0.5 mg: Available in 10-tablet blister strips; 6 or 10 strips per carton
📦 Not all strengths and pack sizes may be available in all regions.
16. Storage Instructions
- Store at or below 25°C
- Keep in a cool, dry place
- Always keep in original packaging
- Keep out of reach of children
17. Registration and Regulatory Details
| Product | Registration Number |
|---|---|
| TRANQIPAM 0.5 mg | X/2.6/83 |
| TRANQIPAM 1 mg | U/2.6/38 |
| TRANQIPAM 2.5 mg | U/2.6/39 |
18. Manufacturer Information
Pharmacare Limited
Healthcare Park
Woodlands Drive, Woodmead 2191
South Africa
Final Thoughts
TRANQIPAM is a trusted treatment for anxiety and related disorders when used responsibly under medical supervision. While highly effective, it carries risks of dependence, sedation, and should be used with caution in specific populations like the elderly or those with other medical conditions.
✅ Always follow your doctor’s instructions
❌ Never share this medicine with others
List of Sources for TRANQIPAM (Lorazepam) Information
- South African Medicines Control Council (MCC) / SAHPRA
- Professional Information Leaflets and Scheduling Guidelines
- https://www.sahpra.org.za
- British National Formulary (BNF)
- Lorazepam monograph: dosage, indications, and contraindications
- https://bnf.nice.org.uk
- U.S. National Library of Medicine – DailyMed
- Lorazepam drug label and prescribing information
- https://dailymed.nlm.nih.gov
- Medscape Drug Reference – Lorazepam
- Clinical pharmacology and safety profile
- https://www.medscape.com
- Micromedex (IBM Watson Health)
- Professional drug information database for lorazepam
- Access via institutional subscription
- Drugs.com – Lorazepam Monograph
- Patient and professional information
- https://www.drugs.com/lorazepam.html
- World Health Organization (WHO) – Essential Medicines List
- Benzodiazepines and international classification
- https://www.who.int/publications
- National Institute on Drug Abuse (NIDA)
- Information on benzodiazepine dependence and abuse
- https://www.drugabuse.gov
- European Medicines Agency (EMA)
- Guidelines on benzodiazepine use and withdrawal
- https://www.ema.europa.eu
- Mayo Clinic – Lorazepam Uses and Safety
- Patient education on lorazepam
- https://www.mayoclinic.org/drugs-supplements/lorazepam-oral-route
- Australian Government – Therapeutic Goods Administration (TGA)
- Consumer Medicines Information (CMI) on lorazepam
- https://www.tga.gov.au
