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Epidiolex Oral Solution and HistaFlex

Determining the interaction of Epidiolex Oral Solution and HistaFlex and the possibility of their joint administration.

Check result:
Epidiolex Oral Solution <> HistaFlex
Relevance: 22.09.2022 Reviewer: Shkutko P.M., M.D., in

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Consumer:

Cannabidiol may cause liver problems, and using it with other medications that can also affect the liver such as acetaminophen may increase that risk. You should avoid or limit the use of alcohol while being treated with these medications. Call your doctor immediately if you have fever, chills, joint pain or swelling, unusual bleeding or bruising, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, abdominal pain, dark urine, pale stools, and/or yellowing of the skin or eyes, as these may be signs and symptoms of liver damage. Talk to your doctor or pharmacist if you have any questions or concerns. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Professional:

MONITOR: Coadministration of cannabidiol with other agents known to induce hepatotoxicity may potentiate the risk of liver injury. Cannabidiol causes dose-related elevations of liver transaminases, both alanine aminotransferase (ALT) and aspartate aminotransferase (AST). In controlled studies, the incidence of ALT elevations above 3 times the upper limit of normal (ULN) was 13% with cannabidiol versus 1% with placebo, and 17% in patients taking cannabidiol 20 mg/kg/day compared to 1% taking 10 mg/kg/day. Less than 1% of cannabidiol-treated patients had ALT or AST levels greater than 20 times the ULN. Some cases required hospitalization. In clinical trials, serum transaminase elevations typically occurred within the first two months of treatment initiation, but up to 18 months were reported in some cases, particularly in patients taking concomitant valproate. Resolution occurred with discontinuation or dosage reduction of cannabidiol and/or concomitant valproate in about two-thirds of the cases. In about one-third of the cases, transaminase elevations resolved during continued cannabidiol treatment, without dose reduction. The majority of ALT elevations occurred in patients taking concomitant valproate. Concomitant use of clobazam also increased the incidence of transaminase elevations, but to a lesser extent. In cannabidiol-treated patients, the incidence of ALT elevations greater than 3 times the ULN was 30% in patients taking both concomitant valproate and clobazam, 21% in patients taking concomitant valproate (without clobazam), 4% in patients taking concomitant clobazam (without valproate), and 3% in patients taking neither drug. Insufficient data are available to assess the risk of concomitant administration of other hepatotoxic drugs. Finally, patients with baseline transaminase levels above the ULN also had higher rates of transaminase elevations during cannabidiol treatment. In patients taking 20 mg/kg/day in controlled trials, the frequency of treatment-emergent ALT elevations greater than 3 times the ULN was 30% when ALT was above the ULN at baseline, compared to 12% when ALT was within the normal range at baseline. No patient taking cannabidiol 10 mg/kg/day experienced ALT elevations greater than 3 times the ULN when ALT was above the ULN at baseline, compared with 2% of patients in whom ALT was within the normal range at baseline.

MANAGEMENT: Caution is advised if cannabidiol is used in patients who are currently receiving or have recently received treatment with other hepatotoxic agents, and vice versa. Serum transaminases and total bilirubin levels should be obtained prior to initiating cannabidiol, and patients with elevated baseline transaminase levels above 3 times the ULN accompanied by elevations in bilirubin above 2 times the ULN should be evaluated. Repeat levels should be obtained at 1 month, 3 months, and 6 months after initiation of cannabidiol treatment, and periodically thereafter or as clinically indicated (e.g., within 1 month following changes in cannabidiol dosage or addition of/changes in medications that are known to impact the liver). Consider more frequent monitoring of serum transaminases and bilirubin in patients who are taking valproate or who have elevated liver enzymes at baseline. Patients who develop clinical signs or symptoms suggestive of hepatic dysfunction (e.g., unexplained nausea, vomiting, right upper quadrant abdominal pain, fatigue, anorexia, jaundice, dark urine) should have serum transaminases and total bilirubin measured promptly, and cannabidiol treatment interrupted or discontinued as appropriate. Cannabidiol should be discontinued in patients with elevations of transaminase levels greater than 3 times the ULN and bilirubin levels greater than 2 times the ULN. Patients with sustained transaminase elevations of greater than 5 times the ULN should also have treatment discontinued. Patients with prolonged elevations of serum transaminases should be evaluated for other possible causes. Also consider dosage adjustment or discontinuation of any coadministered medication that is known to affect the liver.

References
  • "Product Information. Epidiolex (cannabidiol)." Greenwich Biosciences Inc, Carlsbad, CA.
  • Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
Epidiolex Oral Solution

Generic Name: cannabidiol

Brand name: Epidiolex

Synonyms: Epidiolex

HistaFlex

Generic Name: acetaminophen / pyrilamine

Brand name: Berocca, Primaplex, Becomject-100, MVI-12, NephPlex RX, Nephrocaps, B-Ject 100, Therobec, B-Plex, Formula B, Vitaplex, Tri-Vi-Sol, Vi-Daylin ADC, Nephro-Vite Rx, Lipogen, Lipotriad, Lipoflavonoid, Cholinoid, Liponol, Bee-Comp with C, Cholidase, Cota-B-Plex, 1000 BC, Neurodep, Neuroforte-Six, MVI. Pediatric, B-Plex Plus, Nephrolan Rx, Zymacap, Vi-Daylin, Poly-Vi-Sol, Dayalets, Sigtab, Therems, StressTabs, Allbee-C 800, Cefol, Cod Liver Oil, Daily Multiple Vitamins, Daily Vite, Protegra, Sesame St. Vitamins with Extra C, Surbex-T, Theragran, Superplex-T, Vi-Stress, Cod Liver Oil Mint, Animal Shape Vitamins, B-50 Complex, B-Complex 50, Vitamin B Complex 100, Balanced B-100, B-Stress, B-Scorbic, Bee with C, Children's Chewable Multivitamins, Balanced B-50, Balanced B-150, Unicap Capsule, Unicap Jr, Unicap, Optilets-500, Super Plenamins, Vitamins for Hair, Tab-A-Vite, One-A-Day Essentials, Essential Balance, Vi-Daylin Chewable, Sunkist Child Chewable with C, Sunkist Child Chewable, Poly-Vi-Sol Chewable, Fruity Chew, Poly-Vit Chew, Chewable-Vite, Flintstones Multivitamins, Bugs Bunny with Extra C, Flintstones with C Multivitamins, Bounty Bear Vitamins, Garfield Vitamins, Vi-Daylin Drops, Poly-Vi-Sol Drops, Baby Vitamin Drop, Vita Drop, Poly Vit Drops, MVC. SDV, Glutofac, Allbee-C, Nephro-Vite, Vitabee with C, Stress B with C, High Potency B+C, Farbee with C, Surbex with C, Super B Complex, Surbex, Vitamin B-50, Vitamin B-100, Vitamin B-100 T/R, Hexavitamin, Kenwood Therapeutic, Thera, Theravite, Thera-Plus, Oncovite, Beminal-500, High Potency B Complex with B12 and C, Super B-50, Super B-100 TD, Tri-Vit Drops, Stress Formula, One Tab Daily, Vitamin C, E, and Rose Hips, Scotts Emulsion, Stress Formula 600, Tri-Vit, B Complex 50, Mega B, Folgard, Apatate, T-Vites, High B Complex, Theragenerix, Cernevit, Cardiotek, Beminal, Beminal with C Fortis, Bugs Bunny Multiple Vitamins, Fletanol, Male Formula, Allbee with C, Prevital, Surbex Filmtab, T-BMP, Tender Age Vitamin ADC, Watkins Harvest, Foltx, Folgard Rx 22, Cernevit-12, Infuvite, Infuvite Pediatric, Diatx, Vitamin A, D, One-A-Day 50+, Thex Forte, Protegra Cardio, Vitamin Daily Liquid, Rena-Vite Rx, Renal Caps, Icar C, Renaphro, Cerefolin, Dialyvite Rx, Dialyvite 800, Vesselvite, Folbee Plus, Folbee, Folcaps, Combgen, Abidec, Unichem Multivitamin, Topfit Vitamin B Complex, Topfit Vitamin B Complex Forte, Vitamin B Compound Strong, Health Aid Multivitamin, Vitamins, Daflon, Essentiale, Jetepar, Neurobion, Vitamin A and D Concentrate, Centrum 8400, MVI. Adult, Nephronex, Animi-3, Foltrate, Cardiotek Rx, Folbic, Metanx, D-400 international units, Folbalin Plus, Folbalin, Multi Vits with Beta Carotene, Foltabs 800, Folgard Rx, B-Complex with B-12, FaBB, CerefolinNAC, Folamin, DexFol, One-A-Day Men's Health Formula, Rena-Vite, Equaline One Daily Essential, Daily-Vite Men's Formula, Folplex, Folmor, Zycose, Biotin Forte, Vigomar Forte, Vimar, Multi-Delyn, Foleve Plus, Folnate, Folnate Plus, Foleve, B 100 Complex, Renatabs, AllanTex, Cardiotek-Rx, NuFol, Folplex 22, Reno Caps, Ivites Rx, TL Gard, Vita-Respa, Folast, Triphrocaps, Enfolast-N, Enfolast, Neurpath-B, Triveen-CF, Rovin-CF, Vol-Care Rx, Nephrocaps QT, B-Complex SR, Apetigen, L-methylfolate Ca, Me-Cbl NAC, P-5-P, Me-Cbl, MTX Support, Menopause Relief with Lifenol, Vitacirc-B, Alz-Nac, Tri-Vita Drops, Poly-Vita Drops, Prostate 24, Apetex, Folastin, Folbee AR, Metafolbic, Metafolbic Plus, Foltanx, Virt-Vite Forte, Virt-Vite, Foltanx RF, Folbic RF, One Daily Multi-Essential, Flintstones Toddler, Full Spectrum B with C, Metafolbic Plus RF, PoDiaPN, Super Theravite-M, Nature's Bounty Hair Skin & Nails, Total B with C, Hair, Skin, & Nails Gummies, Concentrated Whole Food Multivitamin, Niva-Fol, Glycogenics, SeroSyn, Virt-Vite Plus, Rheumate, Folinic-Plus, Allbee Plus, Av-VITE FB Forte, Celebrate B-12, Virt-Gard, Mebolic, DEKAs Essential, Multi Vitamin+, Xyzbac, Nufola, Folika-T, Hylavite, K2 Plus D3, Dosoquin, VP-Vite Rx, Genicin Vita-S, Genicin Vita-Q, Zyvit, Folika-V, Tobakient, Renal Vitamin, Folic-K, HistaFlex

Synonyms: n.a.

In the course of checking the drug compatibility and interactions, data from the following reference sources was used: Drugs.com, Rxlist.com, Webmd.com, Medscape.com.

Interaction with food and lifestyle
Disease interaction