pregabalin reference
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(pregabalin · DailyMed)
Registered Kenya · PPB

SUMOPREG® 75/60MG

PREGABALIN (AS SUSTAINED RELEASE )75 MG & ETORICOXIB 60 MG BILAYERED TABLETS

H2025/CTD11857/25166 PREGABALIN 75 MG USP & ETORICOXIB 60 MG IH GENERIC/BIOSIMILARS musculo-skeletal system INN generic

What it does

Bilayered is a medication that helps in treating certain conditions. It is formulated to release its ingredients in two phases for better effectiveness.

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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.
H2025/CTD11857/25166
Registration date
-
Expiry date
2030 May 01
Status
Registered
Active ingredient
PREGABALIN (AS SUSTAINED RELEASE )75 MG & ETORICOXIB 60 MG BILAYERED TABLETS
Strength
-
Pack size
PACK SIZE: 10X1X10ALU-ALU BLISTER PRIMARY PACKING MATERIALS: LIDDING ALUMINIUM FOIL PLAIN ALU-ALU FOIL SECONDARY PACKING MATERIALS: CARTON LEAFLET
Therapeutic class
GENERIC/BIOSIMILARS
ATC class (WHO)
M01AH - Coxibs
RxNorm RxCUI
307296
Manufacturer / MAH
Zuvan
Applicant / LTR
JAVIA INTERNATIONAL LIMITED
Country of origin
FOREIGN

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:19:52 · updated 2026-09-25 02:13:16

Drug Interactions

81
Check interactions

Pharmacodynamic Warnings

Etoricoxib appears in TABLE 2: Drugs that cause nephrotoxicity

Etoricoxib appears in TABLE 4: Drugs with antiplatelet effects

Pregabalin appears in TABLE 11: Drugs with CNS depressant effects

Etoricoxib appears in TABLE 16: Drugs that increase serum potassium

Etoricoxib appears in TABLE 18: Drugs that cause hyponatraemia

Severe (8)

Antiepileptics - decreases absorption

Iron chelators (dexrazoxane) might decrease the absorption of antiepileptics (fosphenytoin, phenytoin). Avoid.

Severe Theoretical

Antiepileptics - decreases exposure

Lumacaftor is predicted to decrease the exposure to antiepileptics (carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone). Avoid.

Severe Theoretical

Antiepileptics - decreases concentration

St John’s wort is predicted to decrease the concentration of antiepileptics (fosphenytoin, phenobarbital, phenytoin, primidone). Avoid.

Severe Theoretical

Antiepileptics - increases risk of overheating and dehydration

Hydroxyzine potentially increases the risk of overheating and dehydration when given with antiepileptics (zonisamide). Avoid in children.

Severe Theoretical

Antiepileptics - increases risk of overheating and dehydration

Haloperidol potentially increases the risk of overheating and dehydration when given with antiepileptics (zonisamide). Avoid in children.

Severe Theoretical

Antiepileptics - decreases absorption

Dexrazoxane might decrease the absorption of antiepileptics (fosphenytoin, phenytoin). Avoid.

Severe Theoretical

Antiepileptics - increases risk of overheating and dehydration

Oxybutynin potentially increases the risk of overheating and dehydration when given with antiepileptics (zonisamide). Avoid in children.

Severe Theoretical

Mifamurtide - decreases efficacy

NSAIDs(high-dose)arepredictedtodecreasetheefficacyof mifamurtide.Avoid.rTheoretical

Severe Theoretical

Moderate (30)

Antiarrhythmics - increases exposure

NSAIDs (celecoxib) are predicted to increase the exposure to antiarrhythmics (flecainide, propafenone). Monitor and adjust dose.

Moderate Theoretical

Antiepileptics - increases concentration

Intravenous chloramphenicol increases the concentration of antiepileptics (fosphenytoin, phenytoin) and antiepileptics (fosphenytoin, phenytoin) affect the concentration of intravenous chloramphenicol

Moderate Study

Antiepileptics - decreases concentration

Diazoxide decreases the concentration of antiepileptics (fosphenytoin, phenytoin) and antiepileptics (fosphenytoin, phenytoin) are predicted to decrease the effects of diazoxide. Monitor concentration

Moderate Anecdotal

Antiepileptics - increases concentration

Disulfiramincreasestheconcentrationofantiepileptics (fosphenytoin,phenytoin).Monitorconcentrationandadjust dose.rStudy →AlsoseeTABLE12p.1520

Moderate Study

Antiepileptics - increases concentration

Fluorouracilincreasestheconcentrationofantiepileptics (fosphenytoin,phenytoin).Monitorconcentrationandadjust dose.rAnecdotal 1xidneppA|snoitcaretnI A1 https://www.facebook.c (Books-Courses-Medic

Moderate Anecdotal

Unknown (43)

Alendronate - increases risk of gastrointestinal irritation

NSAIDs are predicted to increase the risk of gastrointestinal irritation when given with bisphosphonates (alendronate, ibandronate).

Unknown Study

Antiepileptics - increases risk of overheating and dehydration

Acetazolamide potentially increases the risk of overheating and dehydration when given with antiepileptics (zonisamide). Avoid in children.

Unknown Theoretical

Antiepileptics - increases risk of visual disturbances

Alcohol potentially increases the risk of visual disturbances when given with antiepileptics (retigabine).

Unknown Study

Antiepileptics - decreases exposure

Enzalutamide is predicted to slightly decrease the exposure to antiepileptics (brivaracetam).

Unknown Theoretical

Antiepileptics - decreases exposure

Apalutamidepotentiallydecreasestheexposureto antiepileptics(valproate).nTheoretical

Unknown Theoretical

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

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About bilayered

Bilayered is a medication that helps in treating certain conditions. It is formulated to release its ingredients in two phases for better effectiveness.

How it works

Bilayered works by slowly releasing its active ingredients in two layers to ensure a more consistent effect over time.

Who it's for

This medication is suitable for individuals who need sustained relief from their condition.

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

About etoricoxib

Etoricoxib is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID) that helps relieve pain and inflammation.

What it treats

  • arthritis
  • gout
  • pain relief after surgery
  • pain from injuries

How it works

Etoricoxib works by blocking certain chemicals in the body that cause pain and swelling, helping to reduce discomfort.

Who it's for

This medicine is for adults who need relief from pain and inflammation.

Drug class

NSAIDs

Cautions

  • • Be cautious if you are taking other medicines that can harm your kidneys.
  • • Avoid if you are using certain blood-thinning medications.
  • • Be careful if you are taking medicines that can raise potassium levels in your blood.
  • • Use with caution if you are on medications that can lower sodium levels.

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

About pregabalin

Pregabalin is a medication used to treat nerve pain and certain types of seizures. It helps calm overactive nerves in the brain.

What it treats

  • nerve pain (neuropathic pain)
  • seizures (epilepsy)
  • anxiety disorders

How it works

Pregabalin works by reducing the number of signals sent by nerves to the brain, which helps decrease pain and seizure activity.

Who it's for

Pregabalin is suitable for adults and some children who have nerve pain or epilepsy.

Drug class

Antiepileptics

Cautions

  • • Be careful if you are taking other medications that can cause drowsiness or slow down brain activity.

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

Clinical monograph: Etoricoxib

BNF-referenced

Etoricoxib is a selective nonsteroidal anti-inflammatory drug (NSAID) belonging to the class of COX-2 inhibitors. It is primarily indicated for the management of pain and inflammation associated with various musculoskeletal disorders, acute gout, and other inflammatory conditions. By selectively inhibiting the COX-2 enzyme, etoricoxib reduces the production of prostaglandins, which play a key role in the inflammatory response, thereby alleviating pain and inflammation.

Indications

  • Pain and inflammation in musculoskeletal disorders
  • Acute gout
  • Osteoarthritis
  • Rheumatoid arthritis
  • Ankylosing spondylitis

Dosage

Children: For children aged 16-17 years, the recommended dose is 120 mg once daily for a maximum of 8 days.

Adults: 120 mg once daily for a maximum of 8 days.

Mechanism of action

Etoricoxib selectively inhibits isoform 2 of the cyclo-oxygenase enzyme (COX-2), preventing the conversion of arachidonic acid to prostaglandins (PGs), which are mediators of inflammation and pain. This selective inhibition results in reduced inflammatory responses without significantly affecting the COX-1 pathway, which is important for maintaining gastrointestinal mucosal integrity.

Pharmacodynamics

Etoricoxib exhibits a high selectivity for COX-2, being about 106 times more selective for COX-2 than for COX-1. This selective action minimizes the gastrointestinal side effects commonly associated with non-selective NSAIDs, as COX-1 plays a protective role in the gastric mucosa. Etoricoxib provides analgesic and anti-inflammatory effects by lowering prostaglandin levels involved in the inflammatory process.

Pharmacokinetics

Etoricoxib is well-absorbed following oral administration, with peak plasma concentrations typically occurring about 1 to 2 hours after ingestion. The drug has a half-life of approximately 22 hours, allowing for once-daily dosing. It is extensively metabolized in the liver, primarily via CYP2C9 and CYP3A4 pathways, and is excreted mainly through urine as metabolites. The presence of food does not significantly affect its absorption.

Contra-indications

  • Active gastrointestinal bleeding
  • Active gastrointestinal ulceration
  • Severe cutaneous adverse reactions (SCARs)
  • Cerebrovascular disease
  • Uncontrolled hypertension (persistently above 140/90 mmHg)
  • Severe renal failure
  • Hypersensitivity to aspirin or other NSAIDs
  • Ischaemic heart disease
  • Active inflammatory bowel disease

Adverse effects

  • Hypertension
  • Fluid retention
  • Gastrointestinal discomfort
  • Nausea
  • Vomiting
  • Headache
  • Dizziness
  • Chest pain
  • Heart failure
  • Palpitations
  • Skin reactions
  • Malaise
  • Nephrotoxicity
  • Insomnia
  • Anemia
  • Visual impairment
  • Aseptic meningitis
  • Tinnitus

Interactions

  • Increased exposure when used with combined hormonal contraceptives
  • Increased exposure when used with hormone replacement therapy
  • May interact with other NSAIDs

Precautions

  • Caution in patients with cardiac impairment
  • Caution in patients with renal impairment
  • Dehydration risk
  • Caution in patients with allergic disorders
  • May mask symptoms of infection

Pregnancy

Avoid unless the potential benefit outweighs the risk, especially during the third trimester due to risk of closure of the fetal ductus arteriosus.

Breast-feeding

Use with caution during breastfeeding; the manufacturer advises avoiding use if possible.

Storage

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

Formulations

  • Modified-release tablet
  • Dispersible tablet
  • Oral suspension
  • Oral solution
BNF 85 (British National Formulary) p.1274 BNF for Children 2019-2020 p.699 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: Pregabalin

BNF-referenced

Pregabalin is an anticonvulsant medication that is structurally related to gamma-aminobutyric acid (GABA). It is primarily used for the management of epilepsy, neuropathic pain, and generalized anxiety disorder. Pregabalin modulates the release of excitatory neurotransmitters by binding to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system, which contributes to its antiseizure and analgesic effects. It does not interact directly with GABA receptors but may enhance GABAergic activity indirectly.

Indications

  • Epilepsy
  • Neuropathic pain
  • Generalized anxiety disorder

Dosage

Adults: The usual starting dose is 150 mg daily, divided into two or three doses. The dose may be increased to a maximum of 600 mg daily based on clinical response and tolerability. Refer to the BNF for specific dosing adjustments in

Mechanism of action

Pregabalin binds presynaptically to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system. This binding modulates the release of several excitatory neurotransmitters, including glutamate, substance P, norepinephrine, and calcitonin gene-related peptide. By preventing the trafficking of the alpha2-delta subunit from the dorsal root ganglia to the spinal dorsal horn, pregabalin contributes to its anticonvulsant and analgesic effects.

Pharmacodynamics

Pregabalin increases the density of GABA transporters in cultured neurons but does not bind directly to GABA-A, GABA-B, or benzodiazepine receptors. It does not affect dopamine, serotonin, or opiate receptors, nor does it modulate sodium channels or cyclooxygenase activity. Its primary action is through the inhibition of excitatory neurotransmitter release, which helps in controlling seizures and alleviating neuropathic pain.

Pharmacokinetics

Pregabalin is rapidly absorbed after oral administration, with peak plasma concentrations usually reached within 1 hour. It has a bioavailability of approximately 90%, and its plasma concentration does not significantly change with increasing doses. Pregabalin is not extensively metabolized; it is primarily excreted unchanged in the urine. The elimination half-life is about 6 hours, and dose adjustments may be necessary in patients with renal impairment.

Adverse effects

  • Dizziness
  • Somnolence
  • Dry mouth
  • Edema
  • Weight gain
  • Blurred vision
  • Difficulty concentrating
  • Euphoria
  • Depression
  • Angioedema

Interactions

  • CNS depressants may enhance the sedative effects of pregabalin
  • Concurrent use with opioids may increase the risk of respiratory depression
  • Antiepileptic drugs may have additive effects

Precautions

  • Use with caution in patients with a history of substance abuse
  • Monitor for signs of angioedema, especially in patients with a history of angioedema
  • Caution in patients with renal impairment, as dosage adjustments may be necessary

Pregnancy

Pregabalin is classified as category C. Animal studies have shown adverse effects, and there are no well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Pregabalin is excreted in breast milk. The effects on a nursing infant are unknown, and caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg
  • Oral solution: 20 mg/mL
  • Chewable tablets: 50 mg
BNF 85 (British National Formulary) p.377 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: bilayered

Bilayered formulations refer to drug delivery systems that have two distinct layers, each potentially containing different active ingredients or release characteristics. This dual-layer design allows for a controlled release of medications, improving therapeutic efficacy and patient compliance. These systems are often used for oral solid dosage forms, providing sustained release of drugs over time.

Indications

  • Chronic pain management
  • Hypertension
  • Diabetes management
  • Cardiovascular diseases
  • Gastroesophageal reflux disease (GERD)
  • Certain psychiatric disorders

Dosage

Children: Dosage for paediatric patients will depend on the specific bilayered formulation and the active ingredients used. Refer to the BNF for Children for detailed dosage information.

Adults: Dosage for adult patients will depend on the specific bilayered formulation and the active ingredients used. Refer to the specific product monograph for detailed dosage information.

Mechanism of action

The mechanism of action of bilayered drug formulations is primarily based on the design of the layers. The outer layer may dissolve quickly to provide an immediate release of the active ingredient, while the inner layer is designed for extended release. This allows for a tailored pharmacokinetic profile where peak plasma concentrations can be achieved quickly, followed by a prolonged therapeutic effect due to the sustained release from the inner layer.

Pharmacodynamics

The pharmacodynamics of bilayered formulations depend on the specific active ingredients used. Generally, the immediate-release layer provides rapid onset of action, while the sustained-release layer maintains drug levels within a therapeutic window for a longer duration. This approach minimizes peaks and troughs in drug concentration, potentially enhancing the overall therapeutic effect and reducing side effects.

Pharmacokinetics

The pharmacokinetics of bilayered formulations are influenced by the solubility and permeability of the active ingredients, as well as the design of the layers. Drugs in the immediate-release layer are absorbed quickly in the gastrointestinal tract, leading to rapid peak plasma concentrations. The sustained-release layer is designed to dissolve gradually, allowing for a prolonged release of the drug over hours. Factors such as gastrointestinal pH, motility, and the presence of food can affect the release and absorption rates.

Pregnancy

The safety of bilayered formulations during pregnancy has not been conclusively established. It is advisable to consult with a healthcare provider before use.

Breast-feeding

It is unknown whether bilayered formulations are excreted in human milk. Caution is recommended, and a healthcare provider should be consulted.

Storage

Store at room temperature, away from moisture and light. 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: Etoricoxib

PubChem CID 123619

Molecular formula: C18H15ClN2O2S

Mechanism of action

Like any other COX-2 selective inhibitor Etoricoxib selectively inhibits isoform 2 of cyclo-oxigenase enzyme (COX-2), preventing production of prostaglandins (PGs) from arachidonic acid.

Pharmacodynamics

Etoricoxib is a COX-2 selective inhibitor (approximately 106 times more selective for COX-2 inhibition over COX-1).

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

Molecular reference: Pregabalin

PubChem CID 5486971

Molecular formula: C8H17NO2

Mechanism of action

Although the mechanism of action has not been fully elucidated, studies involving structurally related drugs suggest that presynaptic binding of pregabalin to voltage-gated calcium channels is key to the antiseizure and antinociceptive effects observed in animal models. By binding presynaptically to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system, pregabalin modulates the release of several excitatory neurotransmitters including glutamate, substance-P, norepinephrine, and calcitonin gene related peptide. In addition, pregabalin prevents the alpha2-delta subunit from being trafficked from the dorsal root ganglia to the spinal dorsal horn, which may also contribute to the mechanism of action. Although pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), it does not bind directly to GABA or benzodiazepine receptors. Pregabalin is an anticonvulsant that is structurally related to the inhibitory CNS neurotransmitter gamma-aminobutyric acid (GABA). Pregabalin also has demonstrated analgesic activity. Although pregabalin was developed as a structural analog of GABA, the drug does not bind directly to GABA-A, GABA-B, or benzodiazepine receptors; does not augment GABA-A responses in cultured neurons; and does not alter brain concentrations of GABA in rats or affect GABA uptake or degradation. However, in cultured neurons, prolonged application of pregabalin increases the density of GABA transporter protein and increases the rate of functional GABA transport. Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in CNS tissues. ... In vitro, pregabalin reduces the calcium-dependent release of several neurotransmitters, including glutamate, norepinephrine, and substance P, possibly by modulation of calcium channel function. Pregabalin does not block sodium channels, is not active at opiate receptors, and does not alter cyclooxygenase enzyme activity. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake. Pregabalin is a potent ligand for the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system that exhibits potent anticonvulsant, analgesic, and anxiolytic activity in a range of animal models. ... Potent binding to the alpha-2-delta site reduces depolarization-induced calcium influx with a consequential modulation in excitatory neurotransmitter release. Pregabalin has no demonstrated effects on GABAergic mechanisms. ... For more Mechanism of Action (Complete) data for PREGABALIN (6 total), please visit the HSDB record page.

Pharmacodynamics

Although the structure of pregabalin is similar to gamma-aminobutyric acid (GABA), it does not bind to GABA receptors. Instead, it binds the alpha2-delta subunit of presynaptic voltage-gated calcium channels in the central nervous system. Pregabalin does not modulate dopamine receptors, serotonin receptors, opiate receptors, sodium channels or cyclooxygenase activity.

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.